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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K042539
Device Name GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL
Applicant
BOSTON SCIENTIFIC CORP.
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538 -6515
Applicant Contact JAMES LEATHLEY
Correspondent
BOSTON SCIENTIFIC CORP.
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538 -6515
Correspondent Contact JAMES LEATHLEY
Regulation Number882.5950
Classification Product Code
HCG  
Date Received09/20/2004
Decision Date 10/19/2004
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
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