FDA 510(k) Application Details - K192344

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K192344
Device Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant	OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33309 US Other 510(k) Applications for this Company
Contact	John Pazienza 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	08/29/2019
Decision Date	09/19/2019
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