ILT ADVANCING MECHANISM, MODEL A115AMI


Device Classification Name

wire, guide, catheter

510(k) Number K021638
Device Name ILT ADVANCING MECHANISM, MODEL A115AMI
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 05/20/2002
Decision Date 07/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No