Arrow Pressure Injectable Midline Catheter
FDA 510(k) clearance K213855 · decided 2022-09-02
Clearance details
- K-number
- K213855
- Device name
- Arrow Pressure Injectable Midline Catheter
- Applicant
- Arrow International, LLC Subsidiary of Teleflex Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2021-12-10
- Decision date
- 2022-09-02
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- PND
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Morrisville, NC, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Midline Catheter (K252402) | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-18 |
| Provena(TM) Midline Catheter (K213203) | C.R. Bard, Inc. | 2022-05-13 |
| Stiletto Extended Dwell Catheter (K210047) | Piper Access, LLC | 2021-08-27 |
| primeMidline Catheters (K192802) | Pfm Medical, Inc. | 2019-10-28 |
| Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter (K181208) | Vygon USA | 2018-11-02 |
| primeMidline Catheters (K173114) | Pfm Medical, Inc. | 2018-03-07 |
| ArchFlo CT Midline (K171483) | Medcomp (Dba Medical Components, Inc.) | 2017-12-15 |
| CT Midline (K170770) | Medical Components, Inc. (dba MedComp) | 2017-07-25 |
| PowerGlide ST Midline Catheter (K170158) | C.R. Bard, Inc. | 2017-06-01 |
| PowerMidline Catheter (K162900) | C.R. Bard, Inc. | 2016-12-14 |
| ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K161313) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-08-24 |
| PowerMidline Catheter (K153393) | C.R. Bard, Inc. | 2016-06-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC recall (Z-2387-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |