FDA 510(k) Application Details - K142300

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K142300
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	HOTSPUR TECHNOLOGIES, INC., A SUBSIDIARY OF TELEFLEX MEDICAL, INC. 880 MAUDE AVENUE, SUITE A MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	ERICK ANKERUD 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	08/18/2014
Decision Date	09/17/2014
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