AXIUM DETACHABLE COIL SYSTEM


Device Classification Name

device, vascular, for promoting embolization

510(k) Number K081465
Device Name AXIUM DETACHABLE COIL SYSTEM
Applicant
MICRO THERAPEUTICS, INC.
9775 toledo way
irvine, 
CA 
92618

Applicant Contact neelu medhekar
Correspondent
MICRO THERAPEUTICS, INC.
9775 toledo way
irvine, 
CA 
92618

Correspodent Contact neelu medhekar
Regulation Number 870.3300
Classification Product Code
KRD  
Date Received 05/27/2008
Decision Date 08/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls