PND — Midline Catheter Class II
FDA product code PND covers "Midline Catheter", a Class II medical device regulated under 21 CFR 880.5200. Submissions are reviewed by the General Hospital panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PND
- Device Class
- Class II
- Regulation Number
- 880.5200
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252402 | terumo medical products (hangzhou) co | Midline Catheter | December 18, 2025 |
| K213855 | arrow international, llc subsidiary of teleflex incorporated | Arrow Pressure Injectable Midline Catheter | September 2, 2022 |
| K213203 | c.r. bard | Provena(TM) Midline Catheter | May 13, 2022 |
| K210047 | piper access | Stiletto Extended Dwell Catheter | August 27, 2021 |
| K192802 | pfm medical | primeMidline Catheters | October 28, 2019 |
| K181208 | vygon usa | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 | November 2, 2018 |
| K173114 | pfm medical | primeMidline Catheters | March 7, 2018 |
| K171483 | medcomp (dba medical components, inc.) | ArchFlo CT Midline | December 15, 2017 |
| K170770 | medical components, inc. (dba medcomp) | CT Midline | July 25, 2017 |
| K170158 | c.r. bard | PowerGlide ST Midline Catheter | June 1, 2017 |
| K162900 | c.r. bard | PowerMidline Catheter | December 14, 2016 |
| K161313 | arrow international, inc. (subsidiary of teleflex, inc.) | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and An | August 24, 2016 |
| K153393 | c.r. bard | PowerMidline Catheter | June 28, 2016 |