K213666 is an FDA 510(k) clearance for the NuCath Wedge Pressure Catheter. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 6, 2022, 318 days after receiving the submission on November 22, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K213666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2021 |
| Decision Date | October 06, 2022 |
| Days to Decision | 318 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |