K252419 is an FDA 510(k) clearance for the HOTWIRE RF GUIDEWIRE (901XXX). This device is classified as a Catheter, Septostomy (Class II - Special Controls, product code DXF).
Submitted by Atraverse Medical, Inc. (Cardiff By The Sea, US). The FDA issued a Cleared decision on August 27, 2025, 26 days after receiving the submission on August 1, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5175.
| 510(k) Number | K252419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2025 |
| Decision Date | August 27, 2025 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXF - Catheter, Septostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5175 |