Data / Medical devices / Mexico / Medtronic Mexico S. de R.L. de CV
Medtronic Mexico S. de R.L. de CV: FDA-registered device maker in Tijuana Baja California, Mexico, 184 510(k) clearances and 9 PMA approvals
Medtronic Mexico S. de R.L. de CV is registered with the FDA (registration 9617601) in Tijuana Baja California, Mexico. It lists 59 device types. The FDA files 184 510(k) clearances and 9 PMA approvals under its listings, the newest dated August 14, 2026. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9617601
- FEI number
- 3002534070
- Address
- Av. Paseo Cucapah 10510 El Lago, Tijuana Baja California, Mexico, C.P. 22210
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- July 30, 1992
- Registered through
- 2026
- Brand names listed
- 6F Launcher Guiding Catheter, 6F Sherpa NX Balanced7F Sherpa NX Balanced, 6F Taiga, AORTIC CUFF, ATRIAL LIFT SYSTEM, AUTOLOG, Accessory Port ATS Medical Thoracic Port System, Achieve and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 184.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 14, 2026 | K261428 | NC Euphora Rapid Exchange Balloon Dilatation Catheter | LOX | Substantially Equivalent | Medtronic Ireland | accessdata.fda.gov |
| July 31, 2026 | K261335 | VitalFlow Set with Balance Biosurface | QJZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 27, 2026 | K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | LOX | Substantially Equivalent | Medtronic Ireland | accessdata.fda.gov |
| January 17, 2026 | K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | LOX | Substantially Equivalent | Medtronic, Ireland | accessdata.fda.gov |
| January 16, 2026 | K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | DTM | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| June 20, 2025 | K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 10, 2025 | K243676 | Duet External Drainage and Monitoring System (EDMS) | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| January 2, 2025 | K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter | QJP | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| October 24, 2024 | K242034 | Duet External Drainage and Monitoring System (EDMS) | PCB | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| September 12, 2024 | K240880 | VitalFlow Set with Balance Biosurface | QJZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 12, 2024 | K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 19, 2024 | K240534 | Bio-Medicus Life Support Catheter and Introducer | QHW | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 23, 2024 | K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | DTR | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| November 7, 2023 | K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | HCG | Substantially Equivalent | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | accessdata.fda.gov |
| August 22, 2023 | K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| June 30, 2023 | K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter | DQY | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| April 6, 2023 | K230640 | Affinity Fusion Oxygenator System | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 14, 2022 | K201057 | Bio-Medicus Life Support Catheter and Introducer | QHW | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 27, 2021 | K211990 | Rist 071 Radial Access Guide Catheter | DQY | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| July 15, 2021 | K201100 | Bio-Medicus Life Support Catheter and Introducer | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 7, 2021 | K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | HCG | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| February 25, 2021 | K210230 | Phenom Catheters | DQY | Substantially Equivalent | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | accessdata.fda.gov |
| November 18, 2020 | K202800 | Pacific Plus PTA Catheter | LIT | Substantially Equivalent | Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) | accessdata.fda.gov |
| July 1, 2020 | K201449 | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring | KRH | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 26, 2020 | K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level | GWM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 9, 2020 | K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags | GWM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 26, 2020 | K200456 | Becker External Drainage and Monitoring System | GWM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 23, 2019 | K191551 | RIST Cath Radial Access Long Sheath | DQY | Substantially Equivalent | Rist Neurovascular, Inc. | accessdata.fda.gov |
| August 27, 2019 | K191077 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor | KFM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 17, 2019 | K191029 | Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 12, 2019 | K183490 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 3, 2019 | K190557 | Bio-Medicus Insertion Kit | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 18, 2019 | K183511 | Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 19, 2018 | K182586 | DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 29, 2018 | K181132 | Tri-Ad 2.0 Adams Tricuspid Band | KRH | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| April 12, 2018 | K173515 | Admiral Xtreme | LIT | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| March 22, 2018 | K180456 | Bio-Medicus Adult Cannulae Kit | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 22, 2018 | K180453 | Bio-Medicus Adult Cannulae and Introducer | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 27, 2017 | K171979 | Tubing Pack | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 2, 2017 | K171308 | Tubing Pack | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 10, 2017 | K162774 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) | DTR | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 1, 2017 | K162958 | MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge | DTR | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 3, 2017 | K162704 | Axium Prime Detachable Coil System | HCG | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| September 21, 2016 | K162016 | Affinity NT Oxygenator with Cortiva BioActive Surface | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 15, 2016 | K153598 | Medtronic Bio-Medicus Adult Cannula Kit | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 28, 2015 | K151447 | Axium Detachable Coil System | HCG | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| July 23, 2015 | K151532 | KYPHON ELEMENT Inflatable Bone Tamp | HRX | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 16, 2015 | K151523 | Uncoated Tubing and Connector Components | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 27, 2015 | K151110 | Intersept Filtered Cardiotomy Reservoir | DTN | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 9, 2015 | K150567 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 2, 2015 | K143480 | Euphora Rapid Exchange Balloon Dilatation Catheter | LOX | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 25, 2015 | K143083 | Bio-Medicus Pediatric Cannula and Introducers | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 7, 2015 | K143107 | DLP Vein Graft Cannula | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| November 18, 2014 | K142673 | Bio-Medicus Adult Cannulae and Introducer | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 24, 2014 | K142784 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 23, 2014 | K133157 | TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 | DRY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 22, 2014 | DEN120017 | Medtronic DUET External Drainage and Monitoring System | PCB | Unknown | Medtronic Neurosurgery | accessdata.fda.gov |
| August 15, 2014 | K141090 | NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER | LOX | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 12, 2014 | K141233 | AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE | DTN | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 30, 2014 | K132730 | BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE | DPT | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 22, 2014 | K140192 | CARPENTIER BI-CAVAL FEMORAL CANNULA | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 20, 2014 | K140165 | MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 10, 2014 | K133310 | AXIUM DETACHABLE COIL SYSTEM | HCG | Substantially Equivalent | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | accessdata.fda.gov |
| November 19, 2013 | K132712 | AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER | KFM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 22, 2013 | K132673 | 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER | DQY | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 29, 2013 | K123358 | PACIFIC PLUS | LIT | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| December 21, 2012 | K123771 | KYPHON EXPRESS II INFLATABLE BONE TAMPS | HRX | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| October 19, 2012 | K122913 | AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| September 14, 2012 | K100645 | AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE | DTZ | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 25, 2012 | K120988 | DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 28, 2011 | K111658 | AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE | KFM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 23, 2011 | K111657 | AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE | KFM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 18, 2011 | K102588 | ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE | DRF | Substantially Equivalent | Medtronic Ablation Frontiers, LLC | accessdata.fda.gov |
| January 24, 2011 | K103231 | KYPHON INFLATION SYRINGE | HRX | Substantially Equivalent | Medtronic Spine, LLC | accessdata.fda.gov |
| December 22, 2010 | K103464 | PACIFIC XTREME PTCA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 16, 2010 | K100646 | AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE | DTM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 22, 2010 | K103095 | SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON | LOX | Substantially Equivalent | Medtronic, Ireland | accessdata.fda.gov |
| October 14, 2010 | K101864 | KYPHON XPANDER II INFLATABLE BONE TAMP | HRX | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| August 7, 2010 | K101212 | MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R | KRH | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 15, 2010 | K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC | KRH | Substantially Equivalent | Genesee Biomedical, Inc. | accessdata.fda.gov |
| June 22, 2010 | K100631 | AFFIITY CP CENTRIFUGAL BLOOD PUMP | KFM | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 10, 2010 | K100274 | MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 30, 2010 | K100921 | ADMIRAL XTREME PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Invatec S.P.A. | accessdata.fda.gov |
| March 22, 2010 | K093535 | AUTOLOG AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 15, 2009 | K092177 | MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 | NTE | Substantially Equivalent | Invatec S.P.A. | accessdata.fda.gov |
| September 18, 2009 | K091559 | MARKSMANN CATHETER | KRA | Substantially Equivalent | Chestnut Medical Technologies, Inc. | accessdata.fda.gov |
| May 7, 2009 | K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC | KRH | Substantially Equivalent | Genesee Biomedical, Inc. | accessdata.fda.gov |
| March 13, 2009 | K083919 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | DQY | Substantially Equivalent | Invatec Innovative Technologies, S.R.L. | accessdata.fda.gov |
| February 27, 2009 | K090046 | CONCERTO DETACHABLE COIL SYSTEM | KRD | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| February 25, 2009 | K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC | KRH | Substantially Equivalent | Genesee Biomedical, Inc. | accessdata.fda.gov |
| August 19, 2008 | K081465 | AXIUM DETACHABLE COIL SYSTEM | KRD | Substantially Equivalent | Micro Therapeutics, Inc. | accessdata.fda.gov |
| March 13, 2008 | K073324 | MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R | KRH | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 23, 2007 | K072655 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR | KRH | Substantially Equivalent | Genesee Biomedical, Inc. | accessdata.fda.gov |
| July 31, 2007 | K071214 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING | KRH | Substantially Equivalent | Genesee Biomedical, Inc. | accessdata.fda.gov |
| July 3, 2007 | K071253 | AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 | DTM | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| March 13, 2007 | K063248 | ARCUATE VERTEBRAL AUGMENTATION SYSTEM | NDN | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| October 18, 2006 | K062809 | ADMIRAL XTREME PTA CATHETER | DQY | Substantially Equivalent | Invatec Innovative Technologies | accessdata.fda.gov |
| May 23, 2006 | K061127 | CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R | KRH | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| January 11, 2006 | K052970 | SIMPLICI-T ANNULOPLASTY SYSTEM | KRH | Substantially Equivalent | Medtronic Heart Valves | accessdata.fda.gov |
| November 17, 2005 | K052899 | ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC | KRH | Substantially Equivalent | Genesee Biomedical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 26, 2021 | P200046 | Harmony TPV System | NPV | 51 | September 30, 2026 | accessdata.fda.gov |
| July 31, 2017 | P170006 | AVALUS(TM) BIOPROSTHESIS | LWR | 42 | July 9, 2026 | accessdata.fda.gov |
| January 27, 2015 | P140017 | MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) | NPV | 33 | June 9, 2026 | accessdata.fda.gov |
| January 17, 2014 | P130021 | MEDTRONIC COREVALVE SYSTEM | NPT | 182 | August 10, 2026 | accessdata.fda.gov |
| April 1, 2011 | P100040 | VALIANT THORACIC STENT GRAFT SYSTEM | MIH | 69 | February 27, 2026 | accessdata.fda.gov |
| December 17, 2010 | P100010 | ARCTIC FRONT CRYOCATHETER SYSTEM | OAE | 151 | September 25, 2026 | accessdata.fda.gov |
| December 16, 2010 | P100021 | MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM | MIH | 129 | May 12, 2026 | accessdata.fda.gov |
| April 17, 2003 | P020045 | 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM | LPB | 102 | April 23, 2026 | accessdata.fda.gov |
| March 24, 1980 | P790017 | USCI DILATATION CATHETER | LOX | 86 | October 27, 2010 | accessdata.fda.gov |
Compare with other makers
- All makers of Oxygenator, Cardiopulmonary Bypass
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Device, Percutaneous, Biopsy
- All makers of System, Endovascular Graft, Aortic Aneurysm Treatment
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Updated September 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.