The following data is part of a premarket notification filed by Pfm Medical, Inc. with the FDA for Primemidline Catheters.
| Device ID | K192802 |
| 510k Number | K192802 |
| Device Name: | PrimeMidline Catheters |
| Classification | Midline Catheter |
| Applicant | PFM Medical, Inc. 1916 Palomar Oaks Way, Suite 150 Carlsbad, CA 92008 |
| Contact | Mina Jiang |
| Correspondent | Mina Jiang 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-10-28 |
| Summary: | summary |