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).
Cleared Devices (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
- NuMED, Inc. — 3 clearances
- Circa Scientific, Inc. — 3 clearances
- Baylis Medical Co., Inc. — 3 clearances
- Atraverse Medical — 2 clearances
- Target Therapeutics — 1 clearance
