COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS


Device Classification Name

filter, intravascular, cardiovascular

510(k) Number K121057
Device Name COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
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 04/06/2012
Decision Date 05/04/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No