HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS


Device Classification Name

device, neurovascular embolization

510(k) Number K080666
Device Name HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
Applicant
MICROVENTION, INC.
75 columbia
suite a
aliso viejo, 
CA 
92656 -1408

Applicant Contact kevin e daly
Correspondent
MICROVENTION, INC.
75 columbia
suite a
aliso viejo, 
CA 
92656 -1408

Correspodent Contact kevin e daly
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 03/10/2008
Decision Date 07/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No