NEURON MAX SYSTEM


Device Classification Name

catheter, percutaneous

510(k) Number K111380
Device Name NEURON MAX 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 870.1250
Classification Product Code
DQY  
Date Received 05/16/2011
Decision Date 07/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No