Data / Medical devices / United States / Medtronic Grand Rapids
Medtronic Grand Rapids: FDA-registered device maker in Grand Rapids, MI, United States, 57 510(k) clearances
Medtronic Grand Rapids is registered with the FDA (registration 3003955307) in Grand Rapids, MI, United States. It lists 20 device types. The FDA files 57 510(k) clearances under its listings, the newest dated January 20, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3003955307
- Address
- 620 Watson SW, Grand Rapids, MI, United States, 49504
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- December 2, 1992
- Registered through
- 2027
- Brand names listed
- ABLATION PEN 4920501 W/PACING, AORTIC CUFF, ATRIAL LIFT SYSTEM, Accessory Port ATS Medical Thoracic Port System, Actuators, Adaptors, Adjustable Slitter, Bio-Medicus 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 20, 2026 | K253998 | Clearview Intracoronary Shunts | DWF | Substantially Equivalent | Medtronic, Inc. | 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 |
| December 7, 2023 | K231206 | DLP Silicone Coronary Artery Ostial Cannulae | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 4, 2023 | K230960 | DLP Silicone Coronary Artery Ostial Cannulae | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 3, 2020 | K200514 | Cardioblate Gemini-s Surgical Ablation Device | OCL | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 30, 2019 | K190623 | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device | OCL | Substantially Equivalent | Medtronic | 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 |
| March 20, 2015 | K150422 | EOPA 3D Arterial Cannula | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 7, 2015 | K143107 | DLP Vein Graft Cannula | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 15, 2014 | K141951 | DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE | DWF | 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 |
| October 31, 2013 | K132995 | DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 14, 2013 | K131425 | NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER | OLO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| July 10, 2013 | K131269 | DLP CORONARY OSTIAL PERFUSION CANNULAE | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 27, 2013 | K123762 | DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF | DWF | 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 14, 2012 | K121451 | CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE | OCL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 25, 2012 | K120612 | MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| December 2, 2011 | K113235 | PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS | DXS | 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 |
| February 26, 2010 | K093203 | CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 | GEI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 5, 2008 | K080509 | CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE | OCL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 18, 2007 | K070288 | CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 | OCL | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| November 22, 2005 | K052524 | BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| September 22, 2005 | K052372 | MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| February 8, 2005 | K043179 | SELECT 3D ARTERIAL CANNULA | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| March 19, 2004 | K040173 | PEDIATRIC AORTIC ROOT CANNULA | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| May 13, 2003 | K031037 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| April 11, 2003 | K030696 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) | DWF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| January 8, 2003 | K024069 | ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 | DWF | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| January 8, 2003 | K022272 | MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) | DWF | Substantially Equivalent | Medtronic Cardiac Surgical Products | accessdata.fda.gov |
| May 3, 2000 | K001153 | MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM | HAW | Substantially Equivalent | Medtronic Surgical Navigation | accessdata.fda.gov |
| December 8, 1997 | K973485 | CLEARVIEW BLOWER/MISTER | FQH | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| March 26, 1996 | K953945 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| April 25, 1995 | K950754 | MACRO SUCTION TUBE MODEL NO 10061 | GCY | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| June 23, 1993 | K924529 | SIGNATURE(TM) CUSTOM TUBING PACK | DWF | Unknown | Avecor Cardiovascular, Inc. | accessdata.fda.gov |
| March 26, 1993 | K924642 | MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER | DWF | Substantially Equivalent | Medtronic Bio-Medicus, Inc. | accessdata.fda.gov |
| July 6, 1990 | K901074 | CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| December 21, 1988 | K884129 | BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET | DQY | Substantially Equivalent | Bio Medicus, Inc. | accessdata.fda.gov |
| March 22, 1988 | K875353 | PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| December 7, 1987 | K872033 | BIO-MEDICUS CANNULA-TUBING | DWF | Substantially Equivalent | Bio Medicus, Inc. | accessdata.fda.gov |
| March 3, 1987 | K865079 | ASPIRATING NEEDLE, CATALOG CODE #12006 | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| March 31, 1986 | K860149 | VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015 | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| February 5, 1986 | K855144 | TOURIQUET KIT WITH SNARE | GDJ | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| June 4, 1985 | K852184 | ELECTRO-CAUTERY KNIFE CLEANER 6000 1 | HAM | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| April 29, 1985 | K850385 | INTRACARDIAC SUMP 12010 | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| April 3, 1985 | K845045 | VENOUS RETURN CATHETER SS-1 | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| June 11, 1984 | K841482 | PRESSURE CATHETER PLACEMENT SET 50010 | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| February 13, 1984 | K840002 | ARTERIAL CANNULA CURVED BEVELED TIP | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| February 13, 1984 | K840001 | ARTERIAL CANNULA STRAIGHT BEVELED TIP | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| January 27, 1984 | K834352 | ADULT VENT CATHETER | DRA | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| January 3, 1984 | K834039 | INFANT VENT CATHETER 12001 W/SIDE VENT | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| November 2, 1981 | K812852 | SET FOR ASEPTIC DECANTING OF A FLEX I.V | KPE | Substantially Equivalent | Dip, Inc. | accessdata.fda.gov |
| April 3, 1981 | K810820 | CARDIOPULMONARY BYPASS | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| March 17, 1981 | K810548 | CARDIOPULMINARY BYPASS CATHETER CANNULA | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
| June 11, 1979 | K790565 | AORTIC ROOT CANNULA | DWF | Substantially Equivalent | Dlp, Inc. | accessdata.fda.gov |
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Updated January 20, 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.