510(k) Report

FDA applicant

Cardio Thoracic Systems

Cupertino, CA3 decisions1986–19990 recalls

FDA records 3 decisions for Cardio Thoracic Systems (Cupertino, CA) from 1986 to 1999: 3 510(k) clearances. Most are in product codes GDW (Staple, Implantable) and MWS (Stabilizer, Heart). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided Cardio Thoracic Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio Thoracic Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardio Thoracic Systems 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?

  • GDWStaple, Implantable1decision
  • MWSStabilizer, Heart1decision
  • GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K992833Vacuum Assist StabilizerCardio Thoracic Systems · 19992cite it
  • K991073Acier SuturesCardio Thoracic Systems · 19992cite it
  • K864146Deknatel Gwathmey Vascular Stapling Kit (Tenative)Cardio Thoracic Systems · 19861cites it

What has FDA decided for it lately?

  • K992833Vacuum Assist StabilizerCardio Thoracic Systems · 1999
  • K991073Acier SuturesCardio Thoracic Systems · 1999
  • K864146Deknatel Gwathmey Vascular Stapling Kit (Tenative)Cardio Thoracic Systems · 1986

All 3 as Cardio Thoracic Systems →