PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM


Device Classification Name

catheter, embolectomy

510(k) Number K121917
Device Name PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
Applicant
PENUMBRA, INC.
1351 harbor bay parkway
alameda, 
CA 
94502

Applicant Contact michaela mahl
Correspondent
PENUMBRA, INC.
1351 harbor bay parkway
alameda, 
CA 
94502

Correspodent Contact michaela mahl
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 07/02/2012
Decision Date 09/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No