FDA 510(k) Application Details - K152665

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K152665
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	NUCYRO VASCULAR, LLC 746 SAN ALESO AVE. SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	MIKE FOURKAS 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	09/17/2015
Decision Date	10/26/2015
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