The following data is part of a premarket notification filed by Pfm Medical, Inc. with the FDA for Primemidline Catheters.
| Device ID | K173114 |
| 510k Number | K173114 |
| Device Name: | PrimeMidline Catheters |
| Classification | Midline Catheter |
| Applicant | PFM Medical, Inc. 1916 Palomar Oaks Way Suite 150 Carlsbad, CA 92008 |
| Contact | Jessica Jho |
| Correspondent | Jessica Jho PFM Medical, Inc. 1916 Palomar Oaks Way Suite 150 Carlsbad, CA 92008 |
| Product Code | PND |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20813623011629 | K173114 | 000 |
| 00813623011588 | K173114 | 000 |
| 20813623011605 | K173114 | 000 |
| 00813623011595 | K173114 | 000 |
| 20813623010158 | K173114 | 000 |
| 20813623010141 | K173114 | 000 |