Medical Device Manufacturer · US , Leechburg , PA

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

12 submissions · 12 cleared · Since 2001

12

Total

12

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Nov 12, 2014

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

Cardiovascular · 86d

Cleared Jul 01, 2014

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

Cardiovascular · 57d

Cleared May 10, 2006

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

Cardiovascular · 29d

Cleared May 27, 2003

COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM

Cardiovascular · 182d

Cleared Apr 25, 2002

COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE

Cardiovascular · 464d

Cleared Jun 14, 2001

COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH

Cardiovascular · 157d