HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE


Device Classification Name

wire, guide, catheter

510(k) Number K072460
Device Name HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
Applicant
ABBOTT VASCULAR, INC.
26531 ynez road
temecula, 
CA 
92590 -3731

Applicant Contact michele walz
Correspondent
ABBOTT VASCULAR, INC.
26531 ynez road
temecula, 
CA 
92590 -3731

Correspodent Contact michele walz
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 08/31/2007
Decision Date 04/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No