MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX


Device Classification Name

device, neurovascular embolization

510(k) Number K111451
Device Name MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
Applicant
MICROVENTION, INC.
1311 valencia ave
tustin, 
CA 
92780

Applicant Contact laraine pangelina
Correspondent
MICROVENTION, INC.
1311 valencia ave
tustin, 
CA 
92780

Correspodent Contact laraine pangelina
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 05/25/2011
Decision Date 09/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No