The following data is part of a premarket notification filed by Pfm Medical, Inc. with the FDA for Nucath Wedge Pressure Catheter.
| Device ID | K213666 |
| 510k Number | K213666 |
| Device Name: | NuCath Wedge Pressure Catheter |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-22 |
| Decision Date | 2022-10-06 |