Product code DXF
- Device name
- Catheter, Septostomy
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5175
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Pressure Products Medical Device Manufacturing, LLC | 2026-03-13 |
| K260292 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical | 2026-02-27 |
| K252419 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical, Inc. | 2025-08-27 |
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | Circa Scientific, Inc. | 2025-05-01 |
| K243193 | Cross Wise™ Multi-Use RF Adapter Cable | Circa Scientific, Inc. | 2024-11-26 |
| K242076 | VersaCross™ RF Wire | Baylis Medical Company | 2024-11-01 |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) | Circa Scientific, Inc. | 2024-09-26 |
| K240900 | HOTWIRE™ RF Guidewire | Atraverse Medical | 2024-05-01 |
| K232852 | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | Cross Vascular, Inc. | 2023-10-12 |
| K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter | Edwards Lifesciences, LLC | 2022-08-22 |
| K211910 | Z-6 Atrioseptostomy Catheter | NuMED, Inc. | 2021-07-19 |
| K182399 | Park Blade Septostomy Catheter | Cook Incorporated | 2019-04-04 |
| K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | 2015-06-17 |
| K073326 | NRG TRANSSEPTAL NEEDLE | Baylis Medical Co., Inc. | 2008-05-28 |
| K031949 | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | Baylis Medical Co., Inc. | 2003-12-10 |
| K011557 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | NuMED, Inc. | 2001-07-12 |
| K990284 | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE | Baylis Medical Co., Inc. | 2001-02-01 |
| K001804 | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER | NuMED, Inc. | 2000-07-12 |
| K860806 | REGULATED PRESSURE INJECTOR | Target Therapeutics | 1986-03-31 |
| K801031 | BLADE SEPTOSTOMY CATHETER | Cook, Inc. | 1980-07-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00685447002628 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2017-10-06 |
| 00685447002611 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2017-10-06 |
| 00685447002604 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2017-10-06 |
| 00685447002598 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2017-10-06 |
| 00685447002581 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2017-10-06 |
| 00685447001508 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001591 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001584 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001577 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001560 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001553 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001546 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001539 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001522 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001515 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001492 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001485 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001478 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001461 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001454 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447001447 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-31 |
| 00685447000518 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-15 |
| 00685447000600 | Nykanen Radiofrequency Wire | Baylis Médicale Cie Inc | 2016-08-15 |
| 00685447000587 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-15 |
| 00685447000570 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-15 |
| 00685447000563 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-15 |
| 00685447000556 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-15 |
| 00685447000549 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-15 |
| 00685447000532 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-15 |
| 00685447000525 | NRG RF Transseptal Kit | Baylis Médicale Cie Inc | 2016-08-15 |