SAPPHIRE DETACHABLE COIL SYSTEM


Device Classification Name

device, neurovascular embolization

510(k) Number K030392
Device Name SAPPHIRE DETACHABLE COIL SYSTEM
Applicant
MICRO THERAPEUTICS, INC.
2 goodyear
irvine, 
CA 
92618

Applicant Contact florin truuvert
Correspondent
MICRO THERAPEUTICS, INC.
2 goodyear
irvine, 
CA 
92618

Correspodent Contact florin truuvert
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 02/05/2003
Decision Date 07/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No