# Cardiothoracic Systems, Inc.

- Location (FDA's records): Cupertino, CA
- FDA decisions: 8 (1997–2001): 8 510(k) clearances
- Product codes: DXC (3), GEI (2), DWF (1), FQH (1), MWS (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 10 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Enable Medical Corp.: 3 (https://510kreport.com/company/enable-medical)
- Cardiva Medical, Inc.: 2 (https://510kreport.com/company/cardiva-medical)
- Sutura, Inc.: 1 (https://510kreport.com/company/sutura)
- AtriCure, Inc.: 1 (https://510kreport.com/company/atricure)
- Lexion Medical, LLC: 1 (https://510kreport.com/company/lexion-medical)
- Ascent Healthcare Solutions: 1 (https://510kreport.com/company/ascent-healthcare-solutions)
- Guidant Corporation, Cardiac Surgery: 1 (https://510kreport.com/company/guidant-cardiac-surgery)

## Its most-cited devices
- K963930: CTS Midcab/SVH Bipolar Scissors (1997), cited by 5
- K970638: CTS Midcab Fixedn Diameter Coronary Shunt (1997), cited by 2
- K963965: CTS Midcab Stitcher (1998), cited by 1
- K983135: Blower/Mister (1998), cited by 1
- K982419: Heart-Lift Balloon Positioner (1999), cited by 1

## Recent decisions
- K010117: Guidant Axius Coronary Shunt (Apr 4, 2001)
- K983270: Voyager Quad Cannula (Jul 28, 1999)
- K982419: Heart-Lift Balloon Positioner (Jan 13, 1999)
- K983135: Blower/Mister (Nov 13, 1998)
- K963965: CTS Midcab Stitcher (Mar 17, 1998)
- K970638: CTS Midcab Fixedn Diameter Coronary Shunt (Oct 30, 1997)
- K963503: CTS Midcab Coronary Shunt (Apr 3, 1997)
- K963930: CTS Midcab/SVH Bipolar Scissors (Jan 16, 1997)

Source page: https://510kreport.com/company/cardiothoracic-systems