510(k) K252402
- Device
- Midline Catheter
- Applicant
- Terumo Medical Products (Hangzhou) Co., Ltd.
- 510(k) number
- K252402
- Product code
- PND
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-18
- Date received
- 2025-07-31
- 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
- N
Applicant Contact#
- Contact
- Kimberly Jacob-Paredes
- Address
- M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou CN 310018 310018
FDA Registration Numbers#
- 3007015148
- 9680794
- 1061124
- 1220477
- 3010273872
- 3013162291
- 3009888344
- 2245270
- 1223004
- 1018233
- 3013666218
- 3030714660
- 3015859709
- 2246552
- 1319211
- 2030624
- 1721686
- 9617592
- 2518902
- 3003915875
- 3007137787
- 1722746
- 3006260740
- 3015537049
- 3004102031
- 3006082230
Source Documents#
Other 510(k) Records For Product Code PND#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |