FDA 510(k) Application Details - K143193

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K143193
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	BOSTON SCIENTIFIC ONE SCIMED PLACE MAPLE GROVE, MN 55311 US Other 510(k) Applications for this Company
Contact	Anna Deraney 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	11/06/2014
Decision Date	07/24/2015
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