# Medtronic Vascular

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 500 (1977–2023): 480 510(k) clearances and 20 original PMA approvals
- Names in FDA's records: Medtronic Vascular (488); Medtronic Vascular, Inc. (12)
- Product codes: DTB (69), DXY (59), GZB (56), DQY (31), LDF (21), DTD (19), DXH (15), DTZ (12), GZJ (10), GXY (10), GZF (8), DYB (7)
- 510(k) review time since 2016: median 111 days, against 95 for FDA's reviews in the same codes and years (3 of 11 faster)
- Predicates its devices cite: 235 (82 its own); citations of its devices by later devices: 303 (82 its own)
- Recalls linked to its devices: 366 (195 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Coalescent Surgical: 14 (https://510kreport.com/company/coalescent-surgical)
- Medtronics Interventional Vascular: 12 (https://510kreport.com/company/medtronics-interventional-vascular)
- Vidamed, Inc.: 7 (https://510kreport.com/company/vidamed)
- Medtronic, Inc.: 6 (https://510kreport.com/company/medtronic)
- Terumo Medical Corp.: 5 (https://510kreport.com/company/terumo-medical)
- Avecor Cardiovascular, Inc.: 5 (https://510kreport.com/company/avecor-cardiovascular)
- Aptus Endosystems, Inc.: 5 (https://510kreport.com/company/aptus-endosystems)
- Hemotec, Inc.: 4 (https://510kreport.com/company/hemotec)

## Firms that cite its devices most
- Medtronic, Inc.: 77 (https://510kreport.com/company/medtronic)
- St Jude Medical: 8 (https://510kreport.com/company/st-jude-medical)
- Spire Biomedical, Inc.: 7 (https://510kreport.com/company/spire-biomedical)
- Medtronic Perfusion Systems: 6 (https://510kreport.com/company/medtronic-perfusion-systems)
- Asahi Intecc Co., Ltd.: 5 (https://510kreport.com/company/asahi-intecc)
- Stimwave Technologies Incorporated: 4 (https://510kreport.com/company/stimwave-technologies)
- AtriCure, Inc.: 4 (https://510kreport.com/company/atricure)
- Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S: 4 (https://510kreport.com/company/alvimedica-tibbi-urunler-sanayi-ve-dis-ticaret-a-s)

## Its most-cited devices
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880 (2002), cited by 12
- K933586: Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive Surface (1994), cited by 8
- K021589: Attain Access 6218A Left-Heart Delivery System, Model 6218 (2002), cited by 8
- K061958: Medtronic Export XT Catheter (2006), cited by 7
- K022764: 7F Launcher Guide Catheter (2002), cited by 7
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218 (2001), cited by 7

## Recent decisions
- K232570: Steerant™ Super Stiff Guidewire (Oct 24, 2023)
- K232190: 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter (Aug 22, 2023)
- K230156: 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter (Jun 30, 2023)
- K220773: Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle  (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle,  4. Torque Handle (AC3205P) (Apr 13, 2022)
- P200026: Abre Venous Self-expanding Stent System (Oct 21, 2020)
- P190008: IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (Nov 21, 2019)
- K192296: Medtronic 6F Taiga Guiding Catheter (Sep 20, 2019)
- K182957: Heli-FX EndoAnchor System (Nov 21, 2018)

Source page: https://510kreport.com/company/medtronic-vascular