COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET


Device Classification Name

filter, intravascular, cardiovascular

510(k) Number K073374
Device Name COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Applicant
WILLIAM COOK EUROPE APS
750 daniels way
p.o. box 489
bloomington, 
IN 
47402 -0489

Applicant Contact molly busenbark
Correspondent
WILLIAM COOK EUROPE APS
750 daniels way
p.o. box 489
bloomington, 
IN 
47402 -0489

Correspodent Contact molly busenbark
Regulation Number 870.3375
Classification Product Code
DTK  
Date Received 12/03/2007
Decision Date 03/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No