# Carbomedics, Inc.

- Location (FDA's records): Austin, TX
- FDA decisions: 23 (1979–1997): 22 510(k) clearances and 1 original PMA approval
- Product codes: LYC (3), DTJ (3), DSY (3), DZE (2), MOP (2), DTI (2), MAL (1), JDL (1), JDI (1), JDG (1), DXO (1), KWL (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 8 (2 its own)
- Recalls linked to its devices: 4 (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)
- Meadox Medicals, Div. Boston Scientific Corp.: 1 (https://510kreport.com/company/meadox-medicals-div-boston-scientific)

## Firms that cite its devices most
- Genzyme Surgical Product (Genzyme Biosurgery): 2 (https://510kreport.com/company/genzyme-surgical-product-genzyme-biosurgery)
- Vascutek, Ltd.: 2 (https://510kreport.com/company/vascutek)
- Sorin Biomedica Cardio S.R.L.: 1 (https://510kreport.com/company/sorin-biomedica-cardio)
- Sulzer Carbomedics, Inc.: 1 (https://510kreport.com/company/sulzer-carbomedics)

## Its most-cited devices
- K951368: Carbomedics Exended Mitral Rotator (1995), cited by 3
- P890045: Gelseal TM Triaxial Vascular Graft (1993), cited by 1
- K942736: Carbomedics (R) Prosthetic Heart Valve Holder Handle (1994), cited by 1
- K964665: Vascutek Gelweave Vascular Graft (Bifurcated Configuration) (1997), cited by 1
- K962154: Carbomedics Handle (1996), cited by 1
- K970375: Annuloflo System (1997), cited by 1

## Recent decisions
- K970375: Annuloflo System (Jul 25, 1997)
- K964665: Vascutek Gelweave Vascular Graft (Bifurcated Configuration) (Feb 19, 1997)
- K962154: Carbomedics Handle (Aug 27, 1996)
- K960923: Carbomedics Mitral Rotator (Apr 29, 1996)
- K960706: Vascutek Vascusoft Plus Vascular Graft (Apr 25, 1996)
- K960169: Carbomedics Valve Tester (Apr 15, 1996)
- K955588: Vascutek Graft Sizer Set (Mar 7, 1996)
- K952184: Carbomedics Supra-Annular Valve Sizer (Nov 29, 1995)

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