FDA 510(k) Application Details - K182360

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K182360
Device Name	Catheter, Percutaneous
Applicant	OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33060 US Other 510(k) Applications for this Company
Contact	John Pazienza 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	08/30/2018
Decision Date	11/09/2018
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