510(k) Report

FDA applicant

Medtronics Interventional Vascular

Danvers, MA23 decisions1988–199945 recalls

FDA records 23 decisions for Medtronics Interventional Vascular (Danvers, MA) from 1988 to 1999: 21 510(k) clearances and 2 original PMA approvals. Most are in product codes DQY (Catheter, Percutaneous) and DQX (Wire, Guide, Catheter). 45 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Medtronics Interventional Vascular’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronics Interventional Vascular since 2007.

Recalls per year

1in 2014

2010: 32011: 12014: 1
2007high 3 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medtronics Interventional Vascular by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQYCatheter, Percutaneous11decisions
  • DQXWire, Guide, Catheter3decisions
  • DQOCatheter, Intravascular, Diagnostic2decisions
  • MAVSyringe, Balloon Inflation2decisions
  • LITCatheter, Angioplasty, Peripheral, Transluminal2decisions
  • MAFStent, Coronary1decision

Also: DTL (1), LOX (1).

Who builds on its devices?

Later devices cite its devices 20 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K950179Medtronic (R) GC Iii Coronary Guiding CatheterMedtronics Interventional Vascular · 19955cite it
  • K990707Medtronic 5F & 9F Zuma Guiding CathetersMedtronics Interventional Vascular · 19992cite it
  • K942269Medtronic Everest Inflation DeviceMedtronics Interventional Vascular · 19942cite it
  • K981198Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 19982cite it
  • K935425Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 19942cite it
  • K950490Medtronic GC IV Coronary Guiding CatheterMedtronics Interventional Vascular · 19952cite it

What has FDA decided for it lately?

  • K990707Medtronic 5F & 9F Zuma Guiding CathetersMedtronics Interventional Vascular · 19995 recalls
  • K980973Medtronic Angiographic CatheterMedtronics Interventional Vascular · 1998
  • K982883Medtronic 7F and 8F Zuma Guiding CatheterMedtronics Interventional Vascular · 199810 recalls
  • K981198Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 199825 recalls
  • K972944Medtronic Mustang Super Floppy Guide Wire/Floppy Guide Wire/Intermediate Guide Wire/Standard Guide…Medtronics Interventional Vascular · 1997
  • P960010Medtronic Wiktor Prime Coronary Stent Delivery SystemMedtronics Interventional Vascular · 1997
  • K961917Medtronic Mustang Steerable Guide Wire (M-45FR, M45FX)Medtronics Interventional Vascular · 1996
  • K960983Medtronic Everst 30 Inflation Device/Survival KitMedtronics Interventional Vascular · 19963 recalls

All 23 as Medtronics Interventional Vascular →

What has been recalled?

45 recalls linked to its devices; the latest:

  • K942269Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The…Feb 6, 2014Class III
  • K010579Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number…Jun 8, 2011
  • K942269Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate…Jul 16, 2010
  • K942269Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate…Jul 16, 2010
  • K942269Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate…Jul 16, 2010
  • K981198CATHETER Z26AL10A Z2 6F 110CM AL10 Z26 AL10 Coronary Guiding catheter designed to…Apr 5, 2006