# Cordis US Corporation

- Location (FDA's records): Miami Lakes
- FDA decisions: 12 (1991–2024): 4 510(k) clearances and 8 original PMA approvals
- Names in FDA's records: Cordis US Corporation (7); Cordis US Corp (5)
- Product codes: MGB (2), NIN (1), NIP (1), MIH (1), QWC (1), DYB (1), DQY (1), DQO (1), LIT (1), NIO (1), NIM (1)
- 510(k) review time since 2016: median 74 days, against 80 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 12 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ClearStream Technologies, Ltd.: 2 (https://510kreport.com/company/clearstream-technologies)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)
- Spectranetics Corp.: 1 (https://510kreport.com/company/spectranetics)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)

## Recent decisions
- K233637: Cordis BRITECROSS Support Catheter (Jun 28, 2024)
- K232573: INFINITI™ Ambi Angiographic Catheter (Nov 21, 2023)
- P220004: PALMAZ MULLINS XD Pulmonary Stent (Jul 21, 2023)
- K230704: RAIN Sheath™ Tibial Pedal Introducer (Apr 24, 2023)
- K221832: SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter (Aug 22, 2022)
- P150002: Incraft (R) Aaa Stent Graft System (Nov 27, 2018)
- P120002: Sma RT Control and Smart Vascular Stent Systems (Nov 7, 2012)
- P100013: Cordis Exoseal Vascular Closure Device (May 19, 2011)

Source page: https://510kreport.com/company/cordis-us