FDA 510(k) Application Details - K143608

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K143608
Device Name	Catheter, Percutaneous
Applicant	Nitiloop Ltd. 8 Hamada St. P.O.Box 12892 Herzliya 46733 IL Other 510(k) Applications for this Company
Contact	Michael A Daniel Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2014
Decision Date	05/04/2015
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