CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH


Device Classification Name

filter, intravascular, cardiovascular

510(k) Number K112119
Device Name CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH
Applicant
WILLIAM COOK EUROPE APS
one geddes way
west lafayette, 
IN 
47906

Applicant Contact jennifer brown
Correspondent
WILLIAM COOK EUROPE APS
one geddes way
west lafayette, 
IN 
47906

Correspodent Contact jennifer brown
Regulation Number 870.3375
Classification Product Code
DTK  
Date Received 07/25/2011
Decision Date 03/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No