FDA 510(k) Application Details - K012985

Device Classification Name	Device, Neurovascular Embolization   More FDA Info for this Device
510(K) Number	K012985
Device Name	Device, Neurovascular Embolization
Applicant	BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	SETH A SCHULMAN Other 510(k) Applications for this Contact
Regulation Number	882.5950   More FDA Info for this Regulation Number
Classification Product Code	HCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2001
Decision Date	01/31/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review