510(k) Report

FDA applicant

Cardiothoracic Systems, Inc.

Cupertino, CA8 decisions1997–20011 recall

FDA records 8 decisions for Cardiothoracic Systems, Inc. (Cupertino, CA) from 1997 to 2001: 8 510(k) clearances. Most are in product codes DXC (Clamp, Vascular) and GEI (Electrosurgical, Cutting & Coagulation &…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Cardiothoracic Systems, Inc. since 2007.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardiothoracic Systems, 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?

  • DXCClamp, Vascular3decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision
  • FQHLavage, Jet1decision
  • MWSStabilizer, Heart1decision

Who builds on its devices?

Later devices cite its devices 10 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.

  • K963930CTS Midcab/SVH Bipolar ScissorsCardiothoracic Systems, Inc. · 19975cite it
  • K970638CTS Midcab Fixedn Diameter Coronary ShuntCardiothoracic Systems, Inc. · 19972cite it
  • K963965CTS Midcab StitcherCardiothoracic Systems, Inc. · 19981cites it
  • K983135Blower/MisterCardiothoracic Systems, Inc. · 19981cites it
  • K982419Heart-Lift Balloon PositionerCardiothoracic Systems, Inc. · 19991cites it

What has FDA decided for it lately?

  • K010117Guidant Axius Coronary ShuntCardiothoracic Systems, Inc. · 2001
  • K983270Voyager Quad CannulaCardiothoracic Systems, Inc. · 1999
  • K982419Heart-Lift Balloon PositionerCardiothoracic Systems, Inc. · 1999
  • K983135Blower/MisterCardiothoracic Systems, Inc. · 19981 recall
  • K963965CTS Midcab StitcherCardiothoracic Systems, Inc. · 1998
  • K970638CTS Midcab Fixedn Diameter Coronary ShuntCardiothoracic Systems, Inc. · 1997
  • K963503CTS Midcab Coronary ShuntCardiothoracic Systems, Inc. · 1997
  • K963930CTS Midcab/SVH Bipolar ScissorsCardiothoracic Systems, Inc. · 1997

All 8 as Cardiothoracic Systems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K983135AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended…Jan 24, 2019Class II