FDA Product Code
FDA Product Code PND — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5200
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252402 | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-18 | Traditional | PDF ↗ |
| K213855 | Arrow Pressure Injectable Midline Catheter | Arrow International, LLC Subsidiary of Teleflex Incorporated | 2022-09-02 | Traditional | PDF ↗ |
| K213203 | Provena(TM) Midline Catheter | C.R. Bard, Inc. | 2022-05-13 | Special | PDF ↗ |
| K210047 | Stiletto Extended Dwell Catheter | Piper Access, LLC | 2021-08-27 | Traditional | PDF ↗ |
| K192802 | primeMidline Catheters | Pfm Medical, Inc. | 2019-10-28 | Special | PDF ↗ |
| K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter | Vygon USA | 2018-11-02 | Traditional | PDF ↗ |
| K173114 | primeMidline Catheters | Pfm Medical, Inc. | 2018-03-07 | Traditional | PDF ↗ |
| K171483 | ArchFlo CT Midline | Medcomp (Dba Medical Components, Inc.) | 2017-12-15 | Traditional | PDF ↗ |
| K170770 | CT Midline | Medical Components, Inc. (dba MedComp) | 2017-07-25 | Special | PDF ↗ |
| K170158 | PowerGlide ST Midline Catheter | C.R. Bard, Inc. | 2017-06-01 | Traditional | PDF ↗ |
| K162900 | PowerMidline Catheter | C.R. Bard, Inc. | 2016-12-14 | Special | PDF ↗ |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-08-24 | Traditional | PDF ↗ |
| K153393 | PowerMidline Catheter | C.R. Bard, Inc. | 2016-06-28 | Traditional | PDF ↗ |
Product code PND · Class II · General Hospital. Data: openFDA.