PENUMBRA SYSTEM


Device Classification Name

catheter, thrombus retriever

510(k) Number K072718
Device Name PENUMBRA SYSTEM
Applicant
PENUMBRA, INC.
2401 merced st., suite 200
san leandro, 
CA 
94577

Applicant Contact theresa brandner-allen
Correspondent
PENUMBRA, INC.
2401 merced st., suite 200
san leandro, 
CA 
94577

Correspodent Contact theresa brandner-allen
Regulation Number 870.1250
Classification Product Code
NRY  
Date Received 09/25/2007
Decision Date 12/28/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls