FDA 510(k) Application Details - K173114

Device Classification Name	More FDA Info for this Device
510(K) Number	K173114
Device Name	primeMidline Catheters
Applicant	PFM Medical, Inc. 1916 Palomar Oaks Way Suite 150 Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Jessica Jho Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PND Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2017
Decision Date	03/07/2018
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