INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5


Device Classification Name

catheter, intravascular, plaque morphology evaluation

510(k) Number K072932
Device Name INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5
Applicant
Infraredx, Inc.
34 third ave
burlington, 
MA 
01803

Applicant Contact steven j chartier
Correspondent
Infraredx, Inc.
34 third ave
burlington, 
MA 
01803

Correspodent Contact steven j chartier
Regulation Number 870.1200
Classification Product Code
OGZ  
Date Received 10/16/2007
Decision Date 04/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No