primeMidline Catheters
by Pfm Medical, Inc. 2 variants
510(k) K173114
primeMidline Catheters is a medical device (FDA Class II; FDA product code PND, Midline Catheter) made by Pfm Medical, Inc., cleared under FDA 510(k) K173114 on 7 Mar 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173114 | Date7 Mar 2018 | StatusActive |
Official records
- FDA 510(k) database K173114
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PND
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K173114
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| primeMidline PFM3SML20 | PFM3SML20 / PFM3SML20 | 00813623011588 | — | On the market |
| primeMIDLINE PFM3SML20N | PFM3SML20N / PFM3SML20N | 00813623010154 | — | On the market |
| primeMIDLINE PFM4SML20 | PFM4SML20 / PFM4SML20 | 00813623011595 | — | On the market |
| primeMIDLINE PFM4SML20N | PFM4SML20N / PFM4SML20N | 00813623010147 | — | On the market |
| primeMidline PFM5DML20 | PFM5DML20 / PFM5DML20 | 00813623011625 | — | On the market |
| primeMIDLINE PFM5SML20 | PFM5SML20 / PFM5SML20 | 00813623011601 | — | On the market |
Similar devices
Other devices filed under FDA product code PND (Midline Catheter).
- ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology by Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- PowerGlide ST Midline Catheter by C. R. Bard, Inc.
- Stiletto Extended Dwell Catheter by Piper Access, LLC
- Arrow Pressure Injectable Midline Catheter by Arrow International LLC (Subsidiary of Teleflex Incorporated)
- CT Midline by Medical Components, Inc. (dba MedComp)
- PowerMidline Catheter by C. R. Bard, Inc.
- ArchFlo CT Midline by Medcomp (Medical Components, Inc.)
- Midline Catheter by Terumo Medical Products (Hangzhou) Co., Ltd.
- Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter by Vygon USA