Cleared Traditional

primeMidline Catheters

K173114 · Pfm Medical, Inc. · General Hospital

Mar 2018

Decision

159d

Days

Class 2

Risk

About This 510(k) Submission

K173114 is an FDA 510(k) clearance for the primeMidline Catheters, a Midline Catheter (Class II — Special Controls, product code PND), submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 7, 2018, 159 days after receiving the submission on September 29, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K173114 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2017
Decision Date	March 07, 2018
Days to Decision	159 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PND — Midline Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.