GDC STRETCH RESISTANT DETACHABLE COIL


Device Classification Name

device, neurovascular embolization

510(k) Number K030475
Device Name GDC STRETCH RESISTANT DETACHABLE COIL
Applicant
BOSTON SCIENTIFIC, TARGET
47900 bayside pkwy.
fremont, 
CA 
94538

Applicant Contact james leathley
Correspondent
BOSTON SCIENTIFIC, TARGET
47900 bayside pkwy.
fremont, 
CA 
94538

Correspodent Contact james leathley
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 02/13/2003
Decision Date 03/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls