Product Code: PND FDA class 2 21 CFR 880.5200

Midline Catheter

General Hospital

The Midline Catheter (product code PND) is a Class 2 general hospital device that is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days, regulated under 880.5200. It requires 510(k) clearance and falls within the general hospital medical specialty. The device is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: PND
Device Class: FDA class 2
Regulation Number: 880.5200
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252402	Midline Catheter	Dec 18, 2025	Substantially Equivalent	Terumo Medical Products (Hangzhou) Co., Ltd.
K213855	Arrow Pressure Injectable Midline Catheter	Sep 02, 2022	Substantially Equivalent	Arrow International, LLC Subsidiary of Teleflex Incorporated
K213203	Provena(TM) Midline Catheter	May 13, 2022	Substantially Equivalent	C.R. Bard, Inc.
K210047	Stiletto Extended Dwell Catheter	Aug 27, 2021	Substantially Equivalent	Piper Access, LLC
K192802	primeMidline Catheters	Oct 28, 2019	Substantially Equivalent	Pfm Medical, Inc.
K181208	Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter	Nov 02, 2018	Substantially Equivalent	Vygon USA
K173114	primeMidline Catheters	Mar 07, 2018	Substantially Equivalent	Pfm Medical, Inc.
K171483	ArchFlo CT Midline	Dec 15, 2017	Substantially Equivalent	Medcomp (Dba Medical Components, Inc.)
K170770	CT Midline	Jul 25, 2017	Substantially Equivalent	Medical Components, Inc. (dba MedComp)
K170158	PowerGlide ST Midline Catheter	Jun 01, 2017	Substantially Equivalent	C.R. Bard, Inc.
K162900	PowerMidline Catheter	Dec 14, 2016	Substantially Equivalent	C.R. Bard, Inc.
K161313	ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology	Aug 24, 2016	Substantially Equivalent	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
K153393	PowerMidline Catheter	Jun 28, 2016	Substantially Equivalent	C.R. Bard, Inc.