ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE


Device Classification Name

wire, guide, catheter

510(k) Number K110009
Device Name ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
Applicant
COOK, INC.
750 daniels way
p.o. box 489
bloomington, 
IN 
47402

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

Correspodent Contact karen bradburn
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 01/03/2011
Decision Date 02/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No