510(k) Report

FDA applicant

Medtronic Percusurge, Inc.

Sunnyvale, CA2 decisions2002–20020 recalls

FDA records 2 decisions for Medtronic Percusurge, Inc. (Sunnyvale, CA) in 2002: 2 510(k) clearances. All are in product code NFA (Temporary Coronary Saphenous Vein Bypass Graft…). No 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, cardiovascular panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medtronic Percusurge, 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?

  • NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2decisions

Who builds on its devices?

Later devices cite its devices 8 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.

  • K013913Percusurge Guardwire Plus Temporary Occlusion and Aspiration SystemMedtronic Percusurge, Inc. · 20026cite it
  • K014223Modification to Guardwire Plus Temporary Occlusion & Aspiration SystemMedtronic Percusurge, Inc. · 20022cite it

What has FDA decided for it lately?

  • K013913Percusurge Guardwire Plus Temporary Occlusion and Aspiration SystemMedtronic Percusurge, Inc. · 2002
  • K014223Modification to Guardwire Plus Temporary Occlusion & Aspiration SystemMedtronic Percusurge, Inc. · 2002

All 2 as Medtronic Percusurge, Inc. →