DXF
- Product code
- DXF
- Device name
- Catheter, Septostomy
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.5175
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 21 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261745 | 2026-06-26 | ElectroWire Medical | LightningWire Transseptal Puncture System (TPS) | FDA |
| K253799 | 2026-03-13 | Pressure Products Medical Device Manuf | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R | |
| K260292 | 2026-02-27 | Atraverse Medical | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE | |
| K252419 | 2025-08-27 | Atraverse Medical, Inc. | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE | |
| K251007 | 2025-05-01 | Circa Scientific, Inc. | CrossWise RF Transseptal Access System (Models: CW-1 | |
| K243193 | 2024-11-26 | Circa Scientific, Inc. | Cross Wise Multi-Use RF Adapter Cable | |
| K242076 | 2024-11-01 | Baylis Medical Company | VersaCross RF Wire | |
| K241414 | 2024-09-26 | Circa Scientific, Inc. | CrossWise RF Transseptal Access System (Models: CW-1 | |
| K240900 | 2024-05-01 | Atraverse Medical | HOTWIRE RF Guidewire | |
| K232852 | 2023-10-12 | Cross Vascular, Inc. | Cross Vascular RF Transseptal Needle, Cross Vascular |
Official FDA classification page: DXF
Classification and pathway per current FDA publications. Data from openFDA (CC0).