# Cordis Corp.

- Location (FDA's records): Miami Lakes, FL
- FDA decisions: 334 (1976–2022): 328 510(k) clearances and 6 original PMA approvals
- Names in FDA's records: Cordis Corp. (321); Cordis Corporation (13)
- Product codes: FGE (38), LIT (30), DQO (29), DQX (25), DQY (22), DYB (22), DXY (21), JXG (18), DTB (13), FJI (8), DTK (5), LDF (5)
- 510(k) review time since 2016: median 115 days, against 125 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 142 (85 its own); citations of its devices by later devices: 219 (85 its own)
- Recalls linked to its devices: 135 (21 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Johnson & Johnson Interventional Systems: 10 (https://510kreport.com/company/johnson-johnson-interventional-systems)
- Cordis Corp., A Johnson & Johnson Co.: 7 (https://510kreport.com/company/cordis-a-johnson-johnson)
- Cook, Inc.: 4 (https://510kreport.com/company/cook)
- Advanced Cardiovascular Systems, Inc.: 3 (https://510kreport.com/company/advanced-cardiovascular-systems)
- Terumo Medical Corp.: 3 (https://510kreport.com/company/terumo-medical)
- Schneider U.S. Stent Div.: 3 (https://510kreport.com/company/schneider-us-stent-div)
- Boston Scientific Scimed, Inc.: 3 (https://510kreport.com/company/boston-scientific-scimed)
- C.R. Bard, Inc.: 3 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- Cordis Corp., A Johnson & Johnson Co.: 11 (https://510kreport.com/company/cordis-a-johnson-johnson)
- Intratherapeutics, Inc.: 6 (https://510kreport.com/company/intratherapeutics)
- Integra LifeSciences Corporation: 6 (https://510kreport.com/company/integra-lifesciences)
- Cordis Europa, N.V.: 6 (https://510kreport.com/company/cordis-europa)
- Guidant Corp.: 6 (https://510kreport.com/company/guidant)
- Cordis Neurovascular, Inc.: 5 (https://510kreport.com/company/cordis-neurovascular)
- Edwards Lifesciences, LLC: 5 (https://510kreport.com/company/edwards-lifesciences)
- Cook, Inc.: 4 (https://510kreport.com/company/cook)

## Its most-cited devices
- K971010: Peripheral Transluminal Angioplasty Catheters (1997), cited by 9
- K964688: Long Medium Palmaz-Schatz Balloon Expandable Stent (1997), cited by 8
- K021898: Smart Control Nitinol Stent Transhepatic Biliary System (2002), cited by 8
- P880003: Cordis Ptca Dilatation Catheter (1988), cited by 7
- K001843: S.M.a.R.T. Nitinol Stent Transhepatic Biliary System (2000), cited by 5
- K960975: 1-4F Infiniti Angiographic Catheter (1996), cited by 5

## Recent decisions
- K220654: ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire (Apr 6, 2022)
- K212977: SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands (Feb 17, 2022)
- K210626: SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (Apr 23, 2021)
- K202167: Brite Tip Radianz Guiding Sheath (Feb 26, 2021)
- K201377: SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter (Oct 9, 2020)
- K201333: SABER .035 PTA Dilatation Catheter (Sep 11, 2020)
- K181592: RAIN Sheath Transradial (Aug 15, 2018)
- K180081: RAILWAY Sheathless Access System (Apr 18, 2018)

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