VENA CAVA FILTER


Device Classification Name

filter, intravascular, cardiovascular

510(k) Number K073528
Device Name VENA CAVA FILTER
Applicant
COOK INCORPORATED
750 daniels way
bloomington, 
IN 
47404

Applicant Contact molly busenbank
Correspondent
COOK INCORPORATED
750 daniels way
bloomington, 
IN 
47404

Correspodent Contact molly busenbank
Regulation Number 870.3375
Classification Product Code
DTK  
Date Received 12/17/2007
Decision Date 02/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No