ADVANCE 18LP PTA DILATATION CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K073378
Device Name ADVANCE 18LP PTA DILATATION CATHETER
Applicant
COOK, INC.
750 daniels way
p.o. box 489
bloomington, 
IN 
47402

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

Correspodent Contact nathan simon
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 12/03/2007
Decision Date 12/28/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No