K253799 is an FDA 510(k) clearance for the SafeSept RF Transseptal Guidewire (SSRF132. This device is classified as a Catheter, Septostomy (Class II - Special Controls, product code DXF).
Submitted by Pressure Products Medical Device Manufacturing, LLC (Morton, US). The FDA issued a Cleared decision on March 13, 2026, 105 days after receiving the submission on November 28, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5175.
| 510(k) Number | K253799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2025 |
| Decision Date | March 13, 2026 |
| Days to Decision | 105 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXF — Catheter, Septostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5175 |