Morton, PA, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DRC | Trocar | Class II | Cardiovascular | 3 | 2024-05-17 |
| DXF | — | — | — | 1 | 2026-03-13 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-13 | K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | DXF | — | — |
| 2024-05-17 | K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | DRC | Class II | Cardiovascular |
| 2022-09-14 | K221707 | SafeSept® Transseptal Guidewire (SS-140) | DRC | Class II | Cardiovascular |
| 2021-03-05 | K210328 | SafeSept Blunt Needle | DRC | Class II | Cardiovascular |