FDA 510(k) Application Details - K021213

Device Classification Name	Graft, Vascular, Synthetic/Biologic Composite   More FDA Info for this Device
510(K) Number	K021213
Device Name	Graft, Vascular, Synthetic/Biologic Composite
Applicant	BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 US Other 510(k) Applications for this Company
Contact	JENNIFER BOLTON Other 510(k) Applications for this Contact
Regulation Number	870.3450   More FDA Info for this Regulation Number
Classification Product Code	MAL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2002
Decision Date	04/19/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review