MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K030019
Device Name MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
Original Applicant
GUIDANT CORP.
4100 hamline avenue north
st. paul, 
MN 
55112 -5798

Original Contact kristine m teich
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 01/03/2003
Decision Date 01/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No