GUNTHER TULIP VENA CAVA FILTER


Device Classification Name

filter, intravascular, cardiovascular

510(k) Number K072240
Device Name GUNTHER TULIP VENA CAVA FILTER
Applicant
COOK, INC.
750 daniels way
p.o. box 489
bloomington, 
IN 
47402

Applicant Contact molly busenbark
Correspondent
COOK, INC.
750 daniels way
p.o. box 489
bloomington, 
IN 
47402

Correspodent Contact molly busenbark
Regulation Number 870.3375
Classification Product Code
DTK  
Date Received 08/13/2007
Decision Date 11/08/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No