AZUR DETACHABLE 35 PLATINUM COIL SYSTEM


Device Classification Name

device, vascular, for promoting embolization

510(k) Number K111307
Device Name AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
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 870.3300
Classification Product Code
KRD  
Date Received 05/10/2011
Decision Date 06/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No