FDA Product Code
FDA Product Code DXF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5175
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261745 | LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical | 2026-06-26 | Traditional | PDF ↗ |
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Pressure Products Medical Device Manufacturing, LLC | 2026-03-13 | Special | PDF ↗ |
| K260292 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical | 2026-02-27 | Special | PDF ↗ |
| K252419 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical, Inc. | 2025-08-27 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| K243193 | Cross Wise Multi-Use RF Adapter Cable | Circa Scientific, Inc. | 2024-11-26 | Special | PDF ↗ |
| K242076 | VersaCross RF Wire | Baylis Medical Company | 2024-11-01 | Special | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K240900 | HOTWIRE RF Guidewire | Atraverse Medical | 2024-05-01 | Traditional | PDF ↗ |
| K232852 | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | Cross Vascular, Inc. | 2023-10-12 | Traditional | PDF ↗ |
| K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter | Edwards Lifesciences, LLC | 2022-08-22 | Traditional | PDF ↗ |
| K211910 | Z-6 Atrioseptostomy Catheter | NuMED, Inc. | 2021-07-19 | Special | PDF ↗ |
| K182399 | Park Blade Septostomy Catheter | Cook Incorporated | 2019-04-04 | Traditional | PDF ↗ |
| K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | 2015-06-17 | Traditional | PDF ↗ |
| K073326 | NRG TRANSSEPTAL NEEDLE | Baylis Medical Co., Inc. | 2008-05-28 | Traditional | PDF ↗ |
| K031949 | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | Baylis Medical Co., Inc. | 2003-12-10 | Traditional | PDF ↗ |
| K011557 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | NuMED, Inc. | 2001-07-12 | Special | PDF ↗ |
| K990284 | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE | Baylis Medical Co., Inc. | 2001-02-01 | Traditional | PDF ↗ |
| K001804 | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER | NuMED, Inc. | 2000-07-12 | Special | PDF ↗ |
| K860806 | REGULATED PRESSURE INJECTOR | Target Therapeutics | 1986-03-31 | Traditional | PDF ↗ |
| K801031 | BLADE SEPTOSTOMY CATHETER | Cook, Inc. | 1980-07-28 | Traditional | PDF ↗ |
Product code DXF · Class II · Cardiovascular. Data: openFDA.