Panels › General Hospital › Product code PND · Class 2
Midline Catheter
Regulation 880.5200
1510(k)s in 12 months (13 all time)
4recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in PND
| Company | 510(k)s | Recalls |
|---|---|---|
| C.R. Bard, Inc. | 4 | 0 |
| ARROW INTERNATIONAL Inc. | 0 | 3 |
| Bard Access Systems, Inc. | 0 | 3 |
| Becton Dickinson & Company | 0 | 3 |
| Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2 | 0 |
| Pfm Medical, Inc. | 2 | 0 |
| Medcomp (Dba Medical Components, Inc.) | 1 | 0 |
| Medical Components, Inc. (dba MedComp) | 1 | 0 |
| Piper Access, LLC | 1 | 0 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2025 | K252402 | Midline Catheter Terumo Medical Products (Hangzhou) Co., Ltd., CN | PND |
| Sep 2, 2022 | K213855 | Arrow Pressure Injectable Midline Catheter Arrow International, LLC Subsidiary of Teleflex Incorporated | PND |
| May 13, 2022 | K213203 | Provena(TM) Midline Catheter C.R. Bard, Inc. | PND |
| Aug 27, 2021 | K210047 | Stiletto Extended Dwell Catheter Piper Access, LLC | PND |
| Oct 28, 2019 | K192802 | primeMidline Catheters Pfm Medical, Inc. | PND |
| Nov 2, 2018 | K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter Vygon USA | PND |
| Mar 7, 2018 | K173114 | primeMidline Catheters Pfm Medical, Inc. | PND |
| Dec 15, 2017 | K171483 | ArchFlo CT Midline Medcomp (Dba Medical Components, Inc.) | PND |
| Jul 25, 2017 | K170770 | CT Midline Medical Components, Inc. (dba MedComp) | PND |
| Jun 1, 2017 | K170158 | PowerGlide ST Midline Catheter C.R. Bard, Inc. | PND |
| Dec 14, 2016 | K162900 | PowerMidline Catheter C.R. Bard, Inc. | PND |
| Aug 24, 2016 | K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | PND |
| Jun 28, 2016 | K153393 | PowerMidline Catheter C.R. Bard, Inc. | PND |
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