510(k) Report

FDA applicant

Medtronic Ave, Inc.

Santa Rosa, CA13 decisions1999–20031 recall

FDA records 13 decisions for Medtronic Ave, Inc. (Santa Rosa, CA) from 1999 to 2003: 13 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and MJN (Catheter, Intravascular Occluding, Temporary). Its devices cite 15 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Medtronic Ave, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Ave, Inc. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medtronic Ave, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FGEStents, Drains And Dilators For The Biliary Ducts11decisions
  • MJNCatheter, Intravascular Occluding, Temporary1decision
  • DQXWire, Guide, Catheter1decision

Whose devices does it build on?

Its devices cite 15 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 9 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.

  • K011080Bridge SE Self-Expanding Stent Delivery SystemMedtronic Ave, Inc. · 20013cite it
  • K011817Bridge FXMedtronic Ave, Inc. · 20013cite it
  • K992569Medtronic Ave Bridge StentMedtronic Ave, Inc. · 19991cites it
  • K993145Medtronic Ave Bridge StentMedtronic Ave, Inc. · 19991cites it
  • K014205Modification to Bridge Self-Expanding Biliary Stent Delivery System (Bridge SE)Medtronic Ave, Inc. · 20021cites it
  • K030633Medtronic Ave Bridge Constant Biliary Stent System or ('ConstantMedtronic Ave, Inc. · 20031cites it

What has FDA decided for it lately?

  • K032768Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L)Medtronic Ave, Inc. · 20031 recall
  • K030633Medtronic Ave Bridge Constant Biliary Stent System or ('ConstantMedtronic Ave, Inc. · 2003
  • K030839Medtronic Ave Bridge Aurora Biliary Stent System (Aurora)Medtronic Ave, Inc. · 2003
  • K022026Medtronic Ave Bridge Polaris Biliary Stent System (Polaris)Medtronic Ave, Inc. · 2002
  • K014205Modification to Bridge Self-Expanding Biliary Stent Delivery System (Bridge SE)Medtronic Ave, Inc. · 2002
  • K011080Bridge SE Self-Expanding Stent Delivery SystemMedtronic Ave, Inc. · 2001
  • K011817Bridge FXMedtronic Ave, Inc. · 2001
  • K002346Wire, Guide, Catheter, Model QSW1000Medtronic Ave, Inc. · 2000

All 13 as Medtronic Ave, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K032768Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a…Jul 30, 2009