primeMidline Catheters
FDA 510(k) K173114 · Pfm Medical, Inc.
510(k) numberK173114
Submission
- Device name
- primeMidline Catheters
- Applicant
- Pfm Medical, Inc.
Carlsbad, CA, US - Received
- September 29, 2017
- Decision date
- March 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K162900 | PowerMidline CatheterPND · Special | C.R. Bard, Inc. | 12/14/2016SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242763 | JetCan® Pro Safety Huber NeedleFPA · Traditional | 05/02/2025SE |
| K241278 | ASEPT® Glide Peritoneal Drainage SystemPNG · Traditional | 01/14/2025SE |
| K221779 | ASEPT Peritoneal Drainage SystemPNG · Traditional | 05/02/2023SESK |
| K213666 | NuCath Wedge Pressure CatheterDQO · Traditional | 10/06/2022SE |
| K201137 | Asept Surgical Face MaskFXX · Abbreviated | 08/19/2020SE |
| K192802 | primeMidline CathetersPND · Special | 10/28/2019SE |
| K140137 | Safety Biopsy Needle SystemFCG · Traditional | 03/25/2014SE |
| K122402 | LPP (Low Profile Port)LJT · Traditional | 07/16/2013SE |
| K113354 | Veta Peritoneal Dialysis CatheterFJS · Traditional | 03/13/2012SESK |
| K110914 | Triple Lumen PFM PiccLJS · Traditional | 09/21/2011SE |
Questions and answers
When was primeMidline Catheters cleared by the FDA?
primeMidline Catheters (K173114) received a 510(k) decision of Substantially Equivalent on March 7, 2018, 159 days after the submission was received.
What is the product code of K173114?
The FDA product code is PND – Midline Catheter, a Class II (moderate risk) device regulated under 21 CFR 880.5200.