PND · Midline Catheter
General Hospital · 21 CFR 880.5200 · Class 2
Overview
| Product Code | PND |
|---|---|
| Device Name | Midline Catheter |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252402 | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | Dec 18, 2025 | SESE |
| K213855 | Arrow Pressure Injectable Midline Catheter | Arrow International, LLC Subsidiary of Teleflex Incorporated | Sep 2, 2022 | SESE |
| K213203 | Provena(TM) Midline Catheter | C.R. Bard, Inc. | May 13, 2022 | SESE |
| K210047 | Stiletto Extended Dwell Catheter | Piper Access, LLC | Aug 27, 2021 | SESE |
| K192802 | primeMidline Catheters | Pfm Medical, Inc. | Oct 28, 2019 | SESE |
| K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter | Vygon USA | Nov 2, 2018 | SESE |
| K173114 | primeMidline Catheters | Pfm Medical, Inc. | Mar 7, 2018 | SESE |
| K171483 | ArchFlo CT Midline | Medcomp (Dba Medical Components, Inc.) | Dec 15, 2017 | SESE |
| K170770 | CT Midline | Medical Components, Inc. (dba MedComp) | Jul 25, 2017 | SESE |
| K170158 | PowerGlide ST Midline Catheter | C.R. Bard, Inc. | Jun 1, 2017 | SESE |
| K162900 | PowerMidline Catheter | C.R. Bard, Inc. | Dec 14, 2016 | SESE |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | Aug 24, 2016 | SESE |
| K153393 | PowerMidline Catheter | C.R. Bard, Inc. | Jun 28, 2016 | SESE |
Top Applicants
- C.R. Bard, Inc. — 4 clearances
- Pfm Medical, Inc. — 2 clearances
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.) — 1 clearance
- Arrow International, LLC Subsidiary of Teleflex Incorporated — 1 clearance
- Medcomp (Dba Medical Components, Inc.) — 1 clearance
