510(k) Report

FDA applicant

Medtronic Ats Medical, Inc.

Minneapolis1 decision2000–20002 recalls

FDA records 1 decision for Medtronic Ats Medical, Inc. (Minneapolis) in 2000: 1 original PMA approval. All are in product code LWQ (Heart-Valve, Mechanical). 2 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 Medtronic Ats Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Ats Medical, Inc. since 2007.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Ats Medical, Inc. 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?

  • LWQHeart-Valve, Mechanical1decision

What has FDA decided for it lately?

  • P990046Ats Open Pivot Bileaflet Heart ValveMedtronic Ats Medical, Inc. · 20002 recalls

The one decision as Medtronic Ats Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • P990046Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mmFeb 11, 2020Class II
  • P990046ATS Open Pivot Mechanical Heart ValveFeb 18, 2004