GDC 360 DETEACHABLE COIL


Device Classification Name

device, neurovascular embolization

510(k) Number K103355
Device Name GDC 360 DETEACHABLE COIL
Applicant
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont, 
CA 
94538 -6515

Applicant Contact rhoda m santos
Correspondent
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont, 
CA 
94538 -6515

Correspodent Contact rhoda m santos
Regulation Number 882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received 11/16/2010
Decision Date 02/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls