PND — Midline Catheter Class II
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 |