FDA 510(k) Application Details - K141933

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K141933
Device Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant	NATEC MEDICAL LTD 5523 RESEARCH PARK DRIVE, SUITE 205 BALTIMORE, MD 21228 US Other 510(k) Applications for this Company
Contact	JUDITH DANIELSON Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2014
Decision Date	06/28/2015
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