HI-TORQUE EXTRA S’PORT GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K021285
Device Name HI-TORQUE EXTRA S’PORT GUIDEWIRE
Original Applicant
GUIDANT CORP.
4100 hamline ave., north
st. paul, 
MN 
55112 -5798

Original Contact karen s alsop
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 04/18/2002
Decision Date 05/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No