# Sulzer Carbomedics, Inc.

- Location (FDA's records): Austin, TX
- FDA decisions: 8 (1998–2002): 8 510(k) clearances
- Product codes: KRH (3), DSY (2), DXZ (2), MOP (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vascutek, Ltd.: 2 (https://510kreport.com/company/vascutek)
- Carbomedics, Inc.: 1 (https://510kreport.com/company/carbomedics)

## Firms that cite its devices most
- Sorin Biomedica Cardio S.R.L.: 2 (https://510kreport.com/company/sorin-biomedica-cardio)
- Lifenet Health: 1 (https://510kreport.com/company/lifenet-health)
- Macropore Biosurgery, Inc.: 1 (https://510kreport.com/company/macropore-biosurgery)
- Peters Surgical: 1 (https://510kreport.com/company/peters-surgical)
- Cryolife, Inc.: 1 (https://510kreport.com/company/cryolife)
- Vascutek, Ltd.: 1 (https://510kreport.com/company/vascutek)
- Medical, Inc.: 1 (https://510kreport.com/company/medical)

## Its most-cited devices
- K993288: Sulzer Carbomedics Cardiofix Pericardium (1999), cited by 3
- K992056: Annuloflex Annuloplasty System, Model AF800 (1999), cited by 2
- K013022: Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis (2002), cited by 1
- K023185: Annuloflex Annuoplasty System, Model AF 800 (2002), cited by 1
- K021051: Annuloflo System, Mitral Model AR700 (2002), cited by 1

## Recent decisions
- K023185: Annuloflex Annuoplasty System, Model AF 800 (Dec 17, 2002)
- K013022: Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis (Jun 13, 2002)
- K021051: Annuloflo System, Mitral Model AR700 (Apr 23, 2002)
- K002007: Sulzer Vascutek Gelsoft Ers Vascular Prosthesis (Jan 25, 2001)
- K993288: Sulzer Carbomedics Cardiofix Pericardium (Dec 29, 1999)
- K992056: Annuloflex Annuloplasty System, Model AF800 (Oct 12, 1999)
- K974648: Sulzer Carbomedics Low Profile Mitral Rotator (Aug 4, 1998)
- K972201: Patch,Pledget and Intracardiac,Petp,Ptfe,Polypropylene (Apr 14, 1998)

Source page: https://510kreport.com/company/sulzer-carbomedics