HYDROCOIL(R) EMBOLIC SYSTEM (HES)


Device Classification Name

device, neurovascular embolization

510(k) Number K112181
Device Name HYDROCOIL(R) EMBOLIC SYSTEM (HES)
Applicant
MICROVENTION, INC.
1311 valencia ave
tustin, 
CA 
92780

Applicant Contact vin cutarelli
Correspondent
MICROVENTION, INC.
1311 valencia ave
tustin, 
CA 
92780

Correspodent Contact vin cutarelli
Regulation Number 882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received 07/28/2011
Decision Date 12/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No