Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
FDA 510(k) K181208 · Vygon USA
510(k) numberK181208
Submission
- Device name
- Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
- Applicant
- Vygon USA
Lansdale, PA, US - Received
- May 7, 2018
- Decision date
- November 2, 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 |
| 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 |
| K162900 | PowerMidline CatheterPND · Special | C.R. Bard, Inc. | 12/14/2016SE |
More from C.R. Bard, Inc.
Questions and answers
When was Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter cleared by the FDA?
Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter (K181208) received a 510(k) decision of Substantially Equivalent on November 2, 2018, 179 days after the submission was received.
What is the product code of K181208?
The FDA product code is PND – Midline Catheter, a Class II (moderate risk) device regulated under 21 CFR 880.5200.