FDA 510(k) Applications for Medical Device Product Code "DXF"
(Catheter, Septostomy)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K240900 | Atraverse Medical | HOTWIREÖ RF Guidewire | 05/01/2024 |
| K990284 | BAYLIS MEDICAL CO., INC. | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE | 02/01/2001 |
| K073326 | BAYLIS MEDICAL CO., INC. | NRG TRANSSEPTAL NEEDLE | 05/28/2008 |
| K031949 | BAYLIS MEDICAL CO., INC. | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | 12/10/2003 |
| K242076 | Baylis Medical Company | VersaCrossÖ RF Wire | 11/01/2024 |
| K150709 | BAYLIS MEDICAL COMPANY INC. | ProTrack RF Anchor Wire | 06/17/2015 |
| K243193 | Circa Scientific, Inc. | Cross WiseÖ Multi-Use RF Adapter Cable | 11/26/2024 |
| K241414 | Circa Scientific, Inc. | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) | 09/26/2024 |
| K251007 | Circa Scientific, Inc. | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | 05/01/2025 |
| K182399 | Cook Incorporated | Park Blade Septostomy Catheter | 04/04/2019 |
| K232852 | Cross Vascular Inc. | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | 10/12/2023 |
| K221528 | Edwards Lifesciences, LLC | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter | 08/22/2022 |
| K001804 | NUMED, INC. | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER | 07/12/2000 |
| K011557 | NUMED, INC. | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | 07/12/2001 |
| K211910 | NuMED, Inc. | Z-6 Atrioseptostomy Catheter | 07/19/2021 |
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