APPROACH PRO ST WIRE GUIDE


Device Classification Name

wire, guide, catheter

510(k) Number K110163
Device Name APPROACH PRO ST WIRE GUIDE
Applicant
COOK INCORPORATED
750 daniels way
bloomington, 
IN 
47404

Applicant Contact aaron santner
Correspondent
COOK INCORPORATED
750 daniels way
bloomington, 
IN 
47404

Correspodent Contact aaron santner
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 01/19/2011
Decision Date 02/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No