HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J


Device Classification Name

wire, guide, catheter

510(k) Number K023300
Device Name HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J
Original Applicant
GUIDANT CORP.
4100 hamline ave., north
st. paul, 
MN 
55112 -5798

Original Contact janell a colley
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 10/03/2002
Decision Date 10/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No