ArchFlo CT Midline

Q: When was ArchFlo CT Midline cleared by the FDA?

ArchFlo CT Midline (K171483) received a 510(k) decision of Substantially Equivalent on December 15, 2017, 207 days after the submission was received.

Q: What is the product code of K171483?

The FDA product code is PND – Midline Catheter, a Class II (moderate risk) device regulated under 21 CFR 880.5200.

FDA 510(k) K171483 · Medcomp (Dba Medical Components, Inc.)

Substantially Equivalent

510(k) numberK171483

Submission

Device name: ArchFlo CT Midline
Applicant: Medcomp (Dba Medical Components, Inc.)
Harleysville, PA, US
Received: May 22, 2017
Decision date: December 15, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PND – Midline Catheter
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5200
Specialty: General Hospital

The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.

Other 510(k)s with product code PND

510(k)	Device	Applicant	Decision
K252402	Midline CatheterPND · Traditional	Terumo Medical Products (Hangzhou) Co., Ltd.	12/18/2025SE
K213855	Arrow Pressure Injectable Midline CatheterPND · Traditional	Arrow International, LLC Subsidiary of Teleflex…	09/02/2022SE
K213203	Provena(TM) Midline CatheterPND · Special	C.R. Bard, Inc.	05/13/2022SE
K210047	Stiletto Extended Dwell CatheterPND · Traditional	Piper Access, LLC	08/27/2021SE
K192802	primeMidline CathetersPND · Special	Pfm Medical, Inc.	10/28/2019SE
K181208	Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…PND · Traditional	Vygon USA	11/02/2018SE
K173114	primeMidline CathetersPND · Traditional	Pfm Medical, Inc.	03/07/2018SE
K170770	CT MidlinePND · Special	Medical Components, Inc. (dba MedComp)	07/25/2017SE
K170158	PowerGlide ST Midline CatheterPND · Traditional	C.R. Bard, Inc.	06/01/2017SE
K162900	PowerMidline CatheterPND · Special	C.R. Bard, Inc.	12/14/2016SE

More from C.R. Bard, Inc.

510(k)	Device	Decision
K171618	Symetrex Long Term Hemodialysis CatheterMSD · Traditional	11/16/2017SESK
K171333	20G x 5/8 Pro-Lock CT Safety Infusion SetPTI · Special	07/18/2017SE

Questions and answers

When was ArchFlo CT Midline cleared by the FDA?

ArchFlo CT Midline (K171483) received a 510(k) decision of Substantially Equivalent on December 15, 2017, 207 days after the submission was received.

What is the product code of K171483?

The FDA product code is PND – Midline Catheter, a Class II (moderate risk) device regulated under 21 CFR 880.5200.