Cook Vascular Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1223-2018Class IIVital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheterNovember 28, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K142301Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheaNovember 12, 2014
K141148EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOJuly 1, 2014
K110347DOPPLER MONITORMarch 16, 2011
K083482COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SETApril 2, 2009
K081425COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORTSeptember 30, 2008
K061000EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0May 10, 2006
K032223COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCHOctober 15, 2003
K023937COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEMMay 27, 2003
K022649COOK-SWARTZ DOPPLER FLOW PROBESeptember 6, 2002
K010128COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVEApril 25, 2002
K002958SHAPEABLE DOPPLER FLOW PROBEDecember 18, 2001
K010055COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATHJune 14, 2001