MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM


Device Classification Name

wire, guide, catheter

510(k) Number K021323
Device Name MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
Original Applicant
INTRALUMINAL THERAPEUTICS, INC.
6354 corte del abeto
suite a
carlsbad, 
CA 
92009

Original Contact pamela misajon
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 04/26/2002
Decision Date 05/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No