LDOB OCCLUSION BALLOON CATHETER


information about

Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K002286
Device Name LDOB OCCLUSION BALLOON CATHETER
Original Applicant
COOK, INC.
925 south curry pike
p.o. box 489
bloomington, 
IN 
47402

Original Contact mary a gossard
Regulation Number 870.4450
Classification Product Code
MJN  
Date Received 07/27/2000
Decision Date 03/22/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No