510(k) K213855
- Device
- Arrow Pressure Injectable Midline Catheter
- Applicant
- Arrow International LLC Subsidiary Of Teleflex Incorporated
- 510(k) number
- K213855
- Product code
- PND
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-09-02
- Date received
- 2021-12-10
- Regulation
- 880.5200
- Classification name
- Midline Catheter
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kim Pennington
- Address
- 3015 Carrington Mill Blvd. Morrisville NC US 27560 27560
FDA Registration Numbers#
- 3007015148
- 1018233
- 9680794
- 3007137787
- 1061124
- 3013666218
- 3006260740
- 3015537049
- 1722746
- 3030714660
- 3013162291
- 9617592
- 1223004
- 3015859709
- 1220477
- 2246552
- 1319211
- 3010273872
- 3006082230
- 2030624
- 3003915875
- 3004102031
- 2245270
- 3009888344
- 2518902
- 1721686
Source Documents#
Other 510(k) Records For Product Code PND #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252402 | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-18 |
| 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 |
Legacy Summary#
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FDA Review#
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