Panels › Cardiovascular › Product code DXF · Class 2
Catheter, Septostomy
Regulation 870.5175
3510(k)s in 12 months (21 all time)
0recalls in 12 months (10 all time)
4recalls that name a 510(k)
Top companies in DXF
| Company | 510(k)s | Recalls |
|---|---|---|
| Baylis Medical Co., Inc. | 5 | 1 |
| Boston Scientific Corporation | 0 | 4 |
| Atraverse Medical | 3 | 0 |
| Circa Scientific, Inc. | 3 | 0 |
| Edwards Lifesciences, LLC | 1 | 2 |
| Medtronic Vascular | 0 | 3 |
| NuMED, Inc. | 3 | 0 |
| Cook Incorporated | 2 | 0 |
| Cross Vascular, Inc. | 1 | 0 |
| ElectroWire Medical | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 2026 | K261745 | LightningWire Transseptal Puncture System (TPS) ElectroWire Medical | DXF |
| Mar 13, 2026 | K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) Pressure Products Medical Device Manufacturing, LLC | DXF |
| Feb 27, 2026 | K260292 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) Atraverse Medical | DXF |
| Aug 27, 2025 | K252419 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) Atraverse Medical, Inc. | DXF |
| May 1, 2025 | K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) Circa Scientific, Inc. | DXF |
| Nov 26, 2024 | K243193 | Cross Wise Multi-Use RF Adapter Cable Circa Scientific, Inc. | DXF |
| Nov 1, 2024 | K242076 | VersaCross RF Wire Baylis Medical Company, CA | DXF |
| Sep 26, 2024 | K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Mo Circa Scientific, Inc. | DXF |
| May 1, 2024 | K240900 | HOTWIRE RF Guidewire Atraverse Medical | DXF |
| Oct 12, 2023 | K232852 | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable Cross Vascular, Inc. | DXF |
| Aug 22, 2022 | K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter Edwards Lifesciences, LLC | DXF |
| Jul 19, 2021 | K211910 | Z-6 Atrioseptostomy Catheter NuMED, Inc. | DXF |
| Apr 4, 2019 | K182399 | Park Blade Septostomy Catheter Cook Incorporated | DXF |
| Jun 17, 2015 | K150709 | ProTrack RF Anchor Wire Baylis Medical Company, Inc., CA | DXF |
| May 28, 2008 | K073326 | NRG TRANSSEPTAL NEEDLE Baylis Medical Co., Inc., CA | DXF |
| Dec 10, 2003 | K031949 | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 Baylis Medical Co., Inc., CA | DXF |
| Jul 12, 2001 | K011557 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS NuMED, Inc. | DXF |
| Feb 1, 2001 | K990284 | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE Baylis Medical Co., Inc., CA | DXF |
| Jul 12, 2000 | K001804 | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER NuMED, Inc. | DXF |
| Mar 31, 1986 | K860806 | REGULATED PRESSURE INJECTOR Target Therapeutics | DXF |
| Jul 28, 1980 | K801031 | BLADE SEPTOSTOMY CATHETER Cook, Inc. | DXF |
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