HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE


Device Classification Name

wire, guide, catheter

510(k) Number K021228
Device Name HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
Original Applicant
GUIDANT CORP.
26531 ynez rd.
temecula, 
CA 
92591 -4630

Original Contact jennifer pae riggs
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 04/18/2002
Decision Date 05/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No