Cleared Special

primeMidline Catheters

K192802 · Pfm Medical, Inc. · General Hospital

Oct 2019

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K192802 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 October 28, 2019, 28 days after receiving the submission on September 30, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K192802 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2019
Decision Date	October 28, 2019
Days to Decision	28 days
Submission Type	Special
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.