Product code PND
- Device name
- Midline Catheter
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5200
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252402 | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-18 |
| K213855 | Arrow Pressure Injectable Midline Catheter | Arrow International, LLC Subsidiary of Teleflex Incorporated | 2022-09-02 |
| K213203 | Provena(TM) Midline Catheter | C.R. Bard, Inc. | 2022-05-13 |
| K210047 | Stiletto Extended Dwell Catheter | Piper Access, LLC | 2021-08-27 |
| K192802 | primeMidline Catheters | Pfm Medical, Inc. | 2019-10-28 |
| K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter | Vygon USA | 2018-11-02 |
| K173114 | primeMidline Catheters | Pfm Medical, Inc. | 2018-03-07 |
| K171483 | ArchFlo CT Midline | Medcomp (Dba Medical Components, Inc.) | 2017-12-15 |
| K170770 | CT Midline | Medical Components, Inc. (dba MedComp) | 2017-07-25 |
| K170158 | PowerGlide ST Midline Catheter | C.R. Bard, Inc. | 2017-06-01 |
| K162900 | PowerMidline Catheter | C.R. Bard, Inc. | 2016-12-14 |
| K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-08-24 |
| K153393 | PowerMidline Catheter | C.R. Bard, Inc. | 2016-06-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10801902213065 | ARROW | TELEFLEX INCORPORATED | 2024-08-01 |
| 10801902201505 | ARROW | TELEFLEX INCORPORATED | 2022-10-13 |
| 10801902201499 | ARROW | TELEFLEX INCORPORATED | 2022-10-13 |
| 10801902201482 | ARROW | TELEFLEX INCORPORATED | 2022-10-13 |
| 10801902205473 | ARROW | TELEFLEX INCORPORATED | 2022-09-30 |
| 10801902205466 | ARROW | TELEFLEX INCORPORATED | 2022-09-30 |
| 10801902205497 | ARROW | TELEFLEX INCORPORATED | 2022-06-03 |
| 10801902205480 | ARROW | TELEFLEX INCORPORATED | 2022-06-03 |
| 10801902188417 | ARROW | TELEFLEX INCORPORATED | 2021-12-14 |
| 10801902188400 | ARROW | TELEFLEX INCORPORATED | 2021-12-14 |
| 10801902189353 | ARROW | TELEFLEX INCORPORATED | 2021-04-05 |
| 10801902161366 | ARROW | TELEFLEX INCORPORATED | 2020-01-24 |
| 10801902158151 | ARROW | TELEFLEX INCORPORATED | 2019-07-25 |
| 10801902156201 | ARROW | TELEFLEX INCORPORATED | 2019-05-14 |
| 08498840012017 | VYGON | Vygon Corporation | 2019-02-26 |
| 08498840012550 | VYGON | Vygon Corporation | 2019-02-26 |
| 08498840012529 | VYGON | Vygon Corporation | 2019-02-26 |
| 08498840012512 | VYGON | Vygon Corporation | 2019-02-26 |
| 08498840012024 | VYGON | Vygon Corporation | 2019-02-26 |
| 08498840012000 | VYGON | Vygon Corporation | 2019-02-26 |
| 10801902144291 | ARROW | TELEFLEX INCORPORATED | 2019-01-07 |
| 10801902144284 | ARROW | TELEFLEX INCORPORATED | 2019-01-07 |
| 10801902143126 | ARROW | TELEFLEX INCORPORATED | 2018-09-10 |
| 10801902136579 | ARROW | TELEFLEX INCORPORATED | 2018-03-08 |
| 10801902136586 | ARROW | TELEFLEX INCORPORATED | 2018-03-07 |
| 10801902139341 | ARROW | TELEFLEX INCORPORATED | 2018-02-12 |
| 10801902137446 | ARROW | TELEFLEX INCORPORATED | 2017-11-23 |
| 10801902137439 | ARROW | TELEFLEX INCORPORATED | 2017-11-17 |
| 10801902130157 | ARROW | TELEFLEX INCORPORATED | 2017-03-30 |
| 10801902130164 | ARROW | TELEFLEX INCORPORATED | 2016-11-11 |