MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K023504
Device Name MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
Original Applicant
COOK, INC.
750 daniels way
p.o. box 489
bloomington, 
IN 
47402 -0489

Original Contact karen bradburn
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 10/18/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No