MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT


Device Classification Name

device, neurovascular embolization

510(k) Number K022735
Device Name MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
Original Applicant
MICROVENTION, INC.
72 argonaut
aliso viejo, 
CA 
92656 -1408

Original Contact vincent cutaurelli
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 08/19/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No