K203793 is an FDA 510(k) clearance for the RithmID-SD Steerable Diagnostic Electrophysiology Catheter. This device is classified as a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II - Special Controls, product code DRF).
Submitted by Synaptic Medical Corporation (Carlsbad, US). The FDA issued a Cleared decision on February 14, 2022, 413 days after receiving the submission on December 28, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K203793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2020 |
| Decision Date | February 14, 2022 |
| Days to Decision | 413 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRF - Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |