MIRAFLEX HIGH FLOW MICROCATHETER


Device Classification Name

catheter, continuous flush

510(k) Number K080737
Device Name MIRAFLEX HIGH FLOW MICROCATHETER
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 870.1210
Classification Product Code
KRA  
Date Received 03/17/2008
Decision Date 08/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No