# Cook Vascular, Inc.

- Location (FDA's records): Vandergrift, PA
- FDA decisions: 12 (2001–2014): 12 510(k) clearances
- Product codes: DRE (4), DYB (2), ITX (2), FPA (1), DPW (1), LJT (1), GEI (1)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 10 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Vascular: 2 (https://510kreport.com/company/medtronic-vascular)
- Command Medical Products: 1 (https://510kreport.com/company/command-medical-products)
- Arthrocare Corp.: 1 (https://510kreport.com/company/arthrocare)
- Med Institute, Inc.: 1 (https://510kreport.com/company/med-institute)
- Thomas Medical Products, Inc.: 1 (https://510kreport.com/company/thomas-medical-products)

## Firms that cite its devices most
- Cook, Inc.: 3 (https://510kreport.com/company/cook)
- Spectranetics Corp.: 1 (https://510kreport.com/company/spectranetics)
- Medtronic Inc. Cardiac Rhythm Management: 1 (https://510kreport.com/company/medtronic-cardiac-rhythm-management)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)

## Its most-cited devices
- K061000: Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 (2006), cited by 3
- K141148: Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set (2014), cited by 2
- K010128: Cook Vascular Peel-Away Hemostasis Valve (2002), cited by 2
- K081425: Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable Port (2008), cited by 2
- K022649: Cook-Swartz Doppler Flow Probe (2002), cited by 1

## Recent decisions
- K142301: Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath (Nov 12, 2014)
- K141148: Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set (Jul 1, 2014)
- K110347: Doppler Monitor (Mar 16, 2011)
- K083482: Cook Vascular Vital-Ject Power Injectable Safety Infusion Set (Apr 2, 2009)
- K081425: Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable Port (Sep 30, 2008)
- K061000: Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 (May 10, 2006)
- K032223: Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent Activation Switch (Oct 15, 2003)
- K023937: Cook Vascular Serpenta Coronary Sinus Introducer System (May 27, 2003)

Source page: https://510kreport.com/company/cook-vascular