FDA 510(k) Application Details - K972357

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K972357
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. NATICK, MA 01760-1537 US Other 510(k) Applications for this Company
Contact	MARY P LEGRAW Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	LIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/1997
Decision Date	11/19/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review