Cook Vascular, Inc.
Medical device manufacturer in Vandergrift, PA.
12510(k) clearances
0PMA approvals
6recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath…DRE · Traditional | 11/12/2014SE |
| K141148 | Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL…DRE · Traditional | 07/01/2014SE |
| K110347 | Doppler MonitorDPW · Special | 03/16/2011SE |
| K083482 | Cook Vascular Vital-Ject Power Injectable Safety Infusion SetFPA · Traditional | 04/02/2009SE |
| K081425 | Cook Vascular Inc. Vital-Port Vascular Access System Power Injectable PortLJT · Traditional | 09/30/2008SE |
| K061000 | Evolution Mechanical Dilator Sheath Set MODELS-LR-EVN-7.0, LR-EVN-9.0DRE · Special | 05/10/2006SE |
| K032223 | Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent…GEI · Traditional | 10/15/2003SE |
| K023937 | Cook Vascular Serpenta Coronary Sinus Introducer SystemDYB · Traditional | 05/27/2003SE |
| K022649 | Cook-Swartz Doppler Flow ProbeITX · Special | 09/06/2002SE |
| K010128 | Cook Vascular Peel-Away Hemostasis ValveDYB · Traditional | 04/25/2002SE |
| K002958 | Shapeable Doppler Flow ProbeITX · Traditional | 12/18/2001SE |
| K010055 | Cook Vascular Electrosurgical Dissection SheathDRE · Traditional | 06/14/2001SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1223-2018 Class II | Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port…Non-coring needle provided with the Cook Vital-Port Vascular Assess System (Vital-Port) may cut or dislodge… | 11/28/2017Terminated |
| Z-2191-2008 | Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm cathetermislabeled - wrong size catheter was packaged in the box | 04/24/2008Terminated |
| Z-2190-2008 | Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheterMislabeled - wrong size catheter was packaged in the box | 04/24/2008Terminated |
| Z-2177-2008 | Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic…mislabeled - 300 micron flexipets labeled as 130 micron and vice versa | 03/02/2008Terminated |
| Z-2176-2008 | Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The…mislabeled - 300 micron flexipets labeled as 130 micron and vice versa | 03/02/2008Terminated |
| Z-2178-2008 | Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10…mislabeled - 300 micron flexipets were labeled as 80 microns | 12/17/2007Terminated |