FDA 510(k) Application Details - K161681

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K161681
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	NIPRO MEDICAL CORPORATION 3150 NW 107TH AVE. MIAMI, FL 33172 US Other 510(k) Applications for this Company
Contact	JESSICA OSWALD-MCLEOD Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2016
Decision Date	03/08/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review