APPROACH CTO WIRE GUIDE


Device Classification Name

wire, guide, catheter

510(k) Number K081337
Device Name APPROACH CTO WIRE GUIDE
Applicant
COOK INCORPORATED
750 daniels way
bloomington, 
IN 
47404

Applicant Contact karen bradburn
Correspondent
COOK INCORPORATED
750 daniels way
bloomington, 
IN 
47404

Correspodent Contact karen bradburn
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 05/13/2008
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