510(k) Report

FDA applicant

Percu Surge, Inc.

Sunnyvale, CA2 decisions1998–20010 recalls

FDA records 2 decisions for Percu Surge, Inc. (Sunnyvale, CA) from 1998 to 2001: 2 510(k) clearances. Most are in product codes NFA (Temporary Coronary Saphenous Vein Bypass Graft…) and MJN (Catheter, Intravascular Occluding, Temporary). 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 Percu Surge, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Percu Surge, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Percu Surge, 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 Protection1decision
  • MJNCatheter, Intravascular Occluding, Temporary1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K003992Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 20013cite it
  • K972777Temporary Occlusion Balloon SystemPercu Surge, Inc. · 19981cites it

What has FDA decided for it lately?

  • K003992Percusurge Guardwire Temporary Occlusion and Aspiration SystemPercu Surge, Inc. · 2001
  • K972777Temporary Occlusion Balloon SystemPercu Surge, Inc. · 1998

All 2 as Percu Surge, Inc. →