FDA 510(k) Application Details - K163231

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K163231
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	AV Medical Technologies Ltd 21b Habarzel Street Tel-Aviv 6971029 IL Other 510(k) Applications for this Company
Contact	Limor Sandach 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	11/17/2016
Decision Date	01/17/2017
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