MODIFIED HD GUIDE CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K080583
Device Name MODIFIED HD GUIDE CATHETER
Applicant
CONCENTRIC MEDICAL, INC.
301 e. evelyn ave.
mountain view, 
CA 
94041

Applicant Contact laraine pangelina
Correspondent
CONCENTRIC MEDICAL, INC.
301 e. evelyn ave.
mountain view, 
CA 
94041

Correspodent Contact laraine pangelina
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 03/03/2008
Decision Date 07/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No