DXF — Catheter, Septostomy Class II
FDA Device Classification
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 |
|---|
| K253799 | pressure products medical device manufacturing | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135 | March 13, 2026 |
| K260292 | atraverse medical | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | February 27, 2026 |
| K252419 | atraverse medical | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | August 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 | November 26, 2024 |
| K242076 | baylis medical | VersaCross RF Wire | November 1, 2024 |
| K241414 | circa scientific | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, C | September 26, 2024 |
| K240900 | atraverse medical | HOTWIRE RF Guidewire | May 1, 2024 |
| K232852 | cross vascular | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | October 12, 2023 |
| K221528 | edwards lifesciences | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Cathet | August 22, 2022 |
| K211910 | numed | Z-6 Atrioseptostomy Catheter | July 19, 2021 |
| K182399 | cook incorporated | Park Blade Septostomy Catheter | April 4, 2019 |
| K150709 | baylis medical company | ProTrack RF Anchor Wire | June 17, 2015 |
| K073326 | baylis medical co | NRG TRANSSEPTAL NEEDLE | May 28, 2008 |
| K031949 | baylis medical co | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | December 10, 2003 |
| K011557 | numed | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | July 12, 2001 |
| K990284 | baylis medical co | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS M | February 1, 2001 |
| K001804 | numed | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER | July 12, 2000 |
| K860806 | target therapeutics | REGULATED PRESSURE INJECTOR | March 31, 1986 |
| K801031 | cook | BLADE SEPTOSTOMY CATHETER | July 28, 1980 |