PowerMidline Catheter
FDA 510(k) K162900 · C.R. Bard, Inc.
510(k) numberK162900
Submission
- Device name
- PowerMidline Catheter
- Applicant
- C.R. Bard, Inc.
Salt Lake Ciy,, UT, US - Received
- October 17, 2016
- Decision date
- December 14, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K171483 | ArchFlo CT MidlinePND · Traditional | Medcomp (Dba Medical Components, Inc.) | 12/15/2017SE |
| 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 |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was PowerMidline Catheter cleared by the FDA?
PowerMidline Catheter (K162900) received a 510(k) decision of Substantially Equivalent on December 14, 2016, 58 days after the submission was received.
What is the product code of K162900?
The FDA product code is PND – Midline Catheter, a Class II (moderate risk) device regulated under 21 CFR 880.5200.