| LightningWire Transseptal Puncture System (TPS) (K261745) | ElectroWire Medical | 2026-06-26 |
| SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) (K253799) | Pressure Products Medical Device Manufacturing, LLC | 2026-03-13 |
| HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (K260292) | Atraverse Medical | 2026-02-27 |
| HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) (K252419) | Atraverse Medical, Inc. | 2025-08-27 |
| CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) (K251007) | Circa Scientific, Inc. | 2025-05-01 |
| Cross Wise™ Multi-Use RF Adapter Cable (K243193) | Circa Scientific, Inc. | 2024-11-26 |
| VersaCross™ RF Wire (K242076) | Baylis Medical Company | 2024-11-01 |
| CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) (K241414) | Circa Scientific, Inc. | 2024-09-26 |
| HOTWIRE™ RF Guidewire (K240900) | Atraverse Medical | 2024-05-01 |
| Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable (K232852) | Cross Vascular, Inc. | 2023-10-12 |
| Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter (K221528) | Edwards Lifesciences, LLC | 2022-08-22 |
| Z-6 Atrioseptostomy Catheter (K211910) | NuMED, Inc. | 2021-07-19 |
| Park Blade Septostomy Catheter (K182399) | Cook Incorporated | 2019-04-04 |
| ProTrack RF Anchor Wire (K150709) | Baylis Medical Company, Inc. | 2015-06-17 |
| NRG TRANSSEPTAL NEEDLE (K073326) | Baylis Medical Co., Inc. | 2008-05-28 |
| TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 (K031949) | Baylis Medical Co., Inc. | 2003-12-10 |
| PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS (K011557) | NuMED, Inc. | 2001-07-12 |
| BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE (K990284) | Baylis Medical Co., Inc. | 2001-02-01 |
| NUMED Z-5 ATRIOSEPTOSTOMY CATHETER (K001804) | NuMED, Inc. | 2000-07-12 |
| REGULATED PRESSURE INJECTOR (K860806) | Target Therapeutics | 1986-03-31 |
| BLADE SEPTOSTOMY CATHETER (K801031) | Cook, Inc. | 1980-07-28 |