DXF — Catheter, Septostomy Class II
FDA product code DXF covers "Catheter, Septostomy", a Class II medical device regulated under 21 CFR 870.5175. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DXF
- Device Class
- Class II
- Regulation Number
- 870.5175
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261745 | Electrowire Medical | LightningWire Transseptal Puncture System (TPS) | Jun 26, 2026 |
| K253799 | Pressure Products Medical Device Manufacturing | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135 | Mar 13, 2026 |
| K260292 | Atraverse Medical | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Feb 27, 2026 |
| K252419 | Atraverse Medical | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Aug 27, 2025 |
| K251007 | Circa Scientific | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW | May 1, 2025 |
| K243193 | Circa Scientific | Cross Wise Multi-Use RF Adapter Cable | Nov 26, 2024 |
| K242076 | Baylis Medical | VersaCross RF Wire | Nov 1, 2024 |
| K241414 | Circa Scientific | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, C | Sep 26, 2024 |
| K240900 | Atraverse Medical | HOTWIRE RF Guidewire | May 1, 2024 |
| K232852 | Cross Vascular | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | Oct 12, 2023 |
| K221528 | Edwards Lifesciences | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Cathet | Aug 22, 2022 |
| K211910 | Numed | Z-6 Atrioseptostomy Catheter | Jul 19, 2021 |
| K182399 | Cook Incorporated | Park Blade Septostomy Catheter | Apr 4, 2019 |
| K150709 | Baylis Medical Company | ProTrack RF Anchor Wire | Jun 17, 2015 |
| K073326 | Baylis Medical Co | NRG TRANSSEPTAL NEEDLE | May 28, 2008 |
| K031949 | Baylis Medical Co | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | Dec 10, 2003 |
| K011557 | Numed | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | Jul 12, 2001 |
| K990284 | Baylis Medical Co | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS M | Feb 1, 2001 |
| K001804 | Numed | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER | Jul 12, 2000 |
| K860806 | Target Therapeutics | REGULATED PRESSURE INJECTOR | Mar 31, 1986 |