DXF · Catheter, Septostomy
Cardiovascular · 21 CFR 870.5175 · Class 2
Overview
| Product Code | DXF |
|---|---|
| Device Name | Catheter, Septostomy |
| Regulation | 21 CFR 870.5175 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Pressure Products Medical Device Manufacturing, LLC | Mar 13, 2026 | SESE |
| K260292 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical | Feb 27, 2026 | SESE |
| K252419 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical, Inc. | Aug 27, 2025 | SESE |
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | Circa Scientific, Inc. | May 1, 2025 | SESE |
| K243193 | Cross Wise Multi-Use RF Adapter Cable | Circa Scientific, Inc. | Nov 26, 2024 | SESE |
| K242076 | VersaCross RF Wire | Baylis Medical Company | Nov 1, 2024 | SESE |
| 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. | Sep 26, 2024 | SESE |
| K240900 | HOTWIRE RF Guidewire | Atraverse Medical | May 1, 2024 | SESE |
| K232852 | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | Cross Vascular, Inc. | Oct 12, 2023 | SESE |
| K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter | Edwards Lifesciences, LLC | Aug 22, 2022 | SESE |
| K211910 | Z-6 Atrioseptostomy Catheter | NuMED, Inc. | Jul 19, 2021 | SESE |
| K182399 | Park Blade Septostomy Catheter | Cook Incorporated | Apr 4, 2019 | SESE |
| K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | Jun 17, 2015 | SESE |
| K073326 | NRG TRANSSEPTAL NEEDLE | Baylis Medical Co., Inc. | May 28, 2008 | SESE |
| K031949 | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | Baylis Medical Co., Inc. | Dec 10, 2003 | SESE |
| K011557 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | NuMED, Inc. | Jul 12, 2001 | SESE |
| K990284 | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE | Baylis Medical Co., Inc. | Feb 1, 2001 | SESE |
| K001804 | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER | NuMED, Inc. | Jul 12, 2000 | SESE |
| K860806 | REGULATED PRESSURE INJECTOR | Target Therapeutics | Mar 31, 1986 | SESE |
| K801031 | BLADE SEPTOSTOMY CATHETER | Cook, Inc. | Jul 28, 1980 | SESE |
Top Applicants
- Baylis Medical Co., Inc. — 3 clearances
- Circa Scientific, Inc. — 3 clearances
- NuMED, Inc. — 3 clearances
- Atraverse Medical — 2 clearances
- Atraverse Medical, Inc. — 1 clearance
