Catheter, Septostomy
FDA product code DXF · Class II (moderate risk) · 21 CFR 870.5175 · Cardiovascular
21510(k) clearances
0PMA approvals
10recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261745 | LightningWire Transseptal Puncture System (TPS)DXF · Traditional | ElectroWire Medical | 06/26/2026SE |
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135…DXF · Special | Pressure Products Medical Device Manufacturing… | 03/13/2026SE |
| K260292 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)DXF · Special | Atraverse Medical | 02/27/2026SE |
| K252419 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)DXF · Traditional | Atraverse Medical, Inc. | 08/27/2025SE |
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C…DXF · Special | Circa Scientific, Inc. | 05/01/2025SE |
| K243193 | Cross Wise Multi-Use RF Adapter CableDXF · Special | Circa Scientific, Inc. | 11/26/2024SE |
| K242076 | VersaCross RF WireDXF · Special | Baylis Medical Company | 11/01/2024SE |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)…DXF · Traditional | Circa Scientific, Inc. | 09/26/2024SE |
| K240900 | HOTWIRE RF GuidewireDXF · Traditional | Atraverse Medical | 05/01/2024SE |
| K232852 | Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableDXF · Traditional | Cross Vascular, Inc. | 10/12/2023SE |
| K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy CatheterDXF · Traditional | Edwards Lifesciences, LLC | 08/22/2022SE |
| K211910 | Z-6 Atrioseptostomy CatheterDXF · Special | NuMED, Inc. | 07/19/2021SE |
| K182399 | Park Blade Septostomy CatheterDXF · Traditional | Cook Incorporated | 04/04/2019SE |
| K150709 | ProTrack RF Anchor WireDXF · Traditional | Baylis Medical Company, Inc. | 06/17/2015SE |
| K073326 | NRG Transseptal NeedleDXF · Traditional | Baylis Medical Co., Inc. | 05/28/2008SE |
| K031949 | Toronto RF Septostomy Catheter, Model TSC-50-75DXF · Traditional | Baylis Medical Co., Inc. | 12/10/2003SE |
| K011557 | Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersDXF · Special | NuMED, Inc. | 07/12/2001SE |
| K990284 | Baylis Medical RF Septostomy Generator, Nykanen RF Septostomy Catheter, Baylis Medical…DXF · Traditional | Baylis Medical Co., Inc. | 02/01/2001SE |
| K001804 | Numed Z-5 Atrioseptostomy CatheterDXF · Special | NuMED, Inc. | 07/12/2000SE |
| K860806 | Regulated Pressure InjectorDXF · Traditional | Target Therapeutics | 03/31/1986SE |
| K801031 | Blade Septostomy CatheterDXF · Traditional | Cook, Inc. | 07/28/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2106-2025 Class II | Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG…Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.… | Boston Scientific Corporation | 06/10/2025Open, Classified |
| Z-2105-2025 Class II | VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS…Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.… | Boston Scientific Corporation | 06/10/2025Open, Classified |
| Z-2104-2025 Class II | VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the…Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.… | Boston Scientific Corporation | 06/10/2025Open, Classified |
| Z-2103-2025 Class II | VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE…Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.… | Boston Scientific Corporation | 06/10/2025Open, Classified |
| Z-0089-2021 Class I | Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen…Subsequent failure of catheters in the field and failed quality testing | Medtronic Vascular | 08/25/2020Terminated |
| Z-0088-2021 Class I | Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen…Subsequent failure of catheters in the field and failed quality testing | Medtronic Vascular | 08/25/2020Terminated |
| Z-0087-2021 Class I | Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric…Subsequent failure of catheters in the field and failed quality testing | Medtronic Vascular | 08/25/2020Terminated |
| Z-1117-2019 Class I | Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF:…Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon… | Edwards Lifesciences, LLC | 03/28/2019Terminated |
| Z-1116-2019 Class I | Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only…Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon… | Edwards Lifesciences, LLC | 03/28/2019Terminated |
| Z-0393-2017 Class II | NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers:…The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the… | Baylis Medical Corp * | 10/11/2016Terminated |