Data / Medical devices / United States / Medtronic Heart Valves Division
Medtronic Heart Valves Division: FDA-registered device maker in Santa Ana, CA, United States, 22 510(k) clearances and 10 PMA approvals
Medtronic Heart Valves Division is registered with the FDA (registration 2025587) in Santa Ana, CA, United States. It lists 12 device types. The FDA files 22 510(k) clearances and 10 PMA approvals under its listings, the newest dated June 13, 2025. 8 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2025587
- Address
- 1851 East Deere Ave., Santa Ana, CA, United States, 92705
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 30, 1992
- Registered through
- 2026
- Brand names listed
- AORTIC CUFF, ATRIAL LIFT SYSTEM, ATS Open Pivot Bi-leaflet, Accessory Port ATS Medical Thoracic Port System, Actuators, Adjustable Slitter, Avalus Sizers, Avalus Valve Handle and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aortic Valve, Prosthesis, Percutaneously Delivered | NPT | 3 | Specification developer | accessdata.fda.gov |
| Electrode, Pacemaker, Temporary | LDF | 2 | Specification developer | accessdata.fda.gov |
| Heart-Valve, Mechanical | LWQ | 3 | Specification developer | accessdata.fda.gov |
| Heart-Valve, Non-Allograft Tissue | LWR | 3 | Manufacturer | accessdata.fda.gov |
| Holder, Heart-Valve, Prosthesis | DTJ | 1 | Manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Specification developer | accessdata.fda.gov |
| Pulmonary Valve Prosthesis Percutaneously Delivered | NPV | f | Manufacturer, Specification developer | accessdata.fda.gov |
| Pulmonic Valved Conduit | MWH | f | Manufacturer | accessdata.fda.gov |
| Replacement Heart-Valve | DYE | 3 | Manufacturer | accessdata.fda.gov |
| Ring, Annuloplasty | KRH | 2 | Specification developer | accessdata.fda.gov |
| Sizer, Heart-Valve, Prosthesis | DTI | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Specification developer | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 13, 2025 | K250075 | Medtronic Stedi Extra Support Guidewire | DQX | Substantially Equivalent | Medtronic, Inc. | 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 |
| August 8, 2019 | K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead | LDF | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 29, 2018 | K181132 | Tri-Ad 2.0 Adams Tricuspid Band | KRH | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 3, 2018 | K181001 | Medtronic Confida Brecker Guidewire | DQX | Substantially Equivalent | Medtronic Core Valve, LLC | accessdata.fda.gov |
| May 25, 2017 | K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead | LDF | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| August 3, 2015 | K150465 | Medtronic Confida Brecker Guidewire | DQX | Substantially Equivalent | Medtronic Core Valve, LLC | accessdata.fda.gov |
| December 19, 2013 | K132623 | MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE | DQX | 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 |
| May 7, 2009 | K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC | KRH | Substantially Equivalent | Genesee Biomedical, 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 |
| 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 |
| 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 |
| November 17, 2005 | K052565 | ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF | KRH | Substantially Equivalent | Genesee Biomedical, Inc. | accessdata.fda.gov |
| November 10, 2005 | K052860 | CG FUTURE ANNULOPLASTY BAND | KRH | Substantially Equivalent | Medtronic Heart Valves | accessdata.fda.gov |
| December 5, 2003 | K032810 | DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE | KRH | Substantially Equivalent | Medtronic Heart Valves | accessdata.fda.gov |
| August 27, 1996 | K960356 | POSTERIOR ANNULOPLASTY BAND (MODEL 607) | KRH | Substantially Equivalent - Subject to Tracking Reg. | The Heart Valve Div. Medtronic Cardiovascular Surg | 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 |
| October 13, 2000 | P990046 | ATS OPEN PIVOT BILEAFLET HEART VALVE | LWQ | 59 | November 7, 2023 | accessdata.fda.gov |
| July 14, 2000 | P990064 | MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE | DYE | 89 | March 3, 2026 | accessdata.fda.gov |
| September 28, 1999 | P980043 | HANCOCK II PORCINE BIOPROSTHESIS | DYE | 78 | February 12, 2026 | accessdata.fda.gov |
| November 26, 1997 | P970031 | MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS | LWR | 70 | February 12, 2026 | accessdata.fda.gov |
| September 28, 1989 | P870078 | HANCOCK PORCINE BIOPROSTHESIS | DYE | 48 | April 22, 2024 | accessdata.fda.gov |
| November 15, 1979 | P790007 | HANCOCK MODIFIED ORIFICE BIOPROSTHESIS | LWR | 62 | April 16, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 22, 2026 | 99031 | Class I | Ongoing | Medtronic Harmony Delivery Catheter System | Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue. | accessdata.fda.gov |
| June 11, 2021 | 88113 | Class II | Ongoing | CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N | Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. | accessdata.fda.gov |
| October 23, 2020 | 86681 | Class II | Terminated | Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EV | Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID). | accessdata.fda.gov |
| January 14, 2020 | 84837 | Class II | Ongoing | Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures. | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue. | accessdata.fda.gov |
| August 3, 2016 | 74796 | Class II | Terminated | Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitan | Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). | accessdata.fda.gov |
| July 15, 2015 | 71719 | Class I | Terminated | EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system. | Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. | accessdata.fda.gov |
| August 15, 2014 | 69089 | Class II | Terminated | Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension. | Medtronic has decided to discontinue production and distribution of this low-volume product. | accessdata.fda.gov |
| January 9, 2014 | 67242 | Class II | Terminated | Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses. | Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-expected transvalvular gradients occurring post implant. | accessdata.fda.gov |
Compare with other makers
- All makers of Heart-Valve, Non-Allograft Tissue
- All makers of Wire, Guide, Catheter
- All makers of Electrode, Pacemaker, Temporary
- All makers of Ring, Annuloplasty
- All makers of Replacement Heart-Valve
- All makers of Instruments, Surgical, Cardiovascular
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.