Medical Device Manufacturer · US , Leechburg , PA

Cook Vascular, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2001

Recent clearances: Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath, EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET, DOPPLER MONITOR

View 12 510(k) Devices ↓

Total

Cleared

Denied

Cook Vascular, Inc. has 12 FDA 510(k) cleared medical devices. Based in Leechburg, US.

Historical record: 12 cleared submissions from 2001 to 2014. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Cook Vascular, Inc. Filter by specialty or product code using the sidebar.

Cook Vascular, Inc. is one of 19157 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Cook Vascular, Inc.

12 devices

1-12 of 12

Cleared Nov 12, 2014

Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator...

K142301 · DRE

Cardiovascular · 86d

Cleared Jul 01, 2014

EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL...

COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET

K083482 · FPA

General Hospital · 129d

Cleared Sep 30, 2008

COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT

K081425 · LJT

General Hospital · 132d

Cleared May 10, 2006

EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0

K061000 · DRE

Cardiovascular · 29d

Cleared Oct 15, 2003

COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC...

K032223 · GEI

General & Plastic Surgery · 86d

Cleared May 27, 2003

COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM

K023937 · DYB

Cardiovascular · 182d

Cleared Sep 06, 2002

COOK-SWARTZ DOPPLER FLOW PROBE

K022649 · ITX

Radiology · 28d

Cleared Apr 25, 2002

COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE

K010128 · DYB

Cardiovascular · 464d

Cleared Dec 18, 2001

SHAPEABLE DOPPLER FLOW PROBE

K002958 · ITX

Radiology · 452d

Cleared Jun 14, 2001

COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH

K010055 · DRE

Cardiovascular · 157d

Cook Vascular, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Cook Vascular, Inc.

Filters