Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5175](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5175) → DXF — Catheter, Septostomy # DXF · Catheter, Septostomy _Cardiovascular · 21 CFR 870.5175 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF ## Overview - **Product Code:** DXF - **Device Name:** Catheter, Septostomy - **Regulation:** [21 CFR 870.5175](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5175) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K253799.md) | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Pressure Products Medical Device Manufacturing, LLC | Mar 13, 2026 | SESE | | [K260292](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K260292.md) | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical | Feb 27, 2026 | SESE | | [K252419](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K252419.md) | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical, Inc. | Aug 27, 2025 | SESE | | [K251007](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K251007.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K243193.md) | Cross Wise™ Multi-Use RF Adapter Cable | Circa Scientific, Inc. | Nov 26, 2024 | SESE | | [K242076](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K242076.md) | VersaCross™ RF Wire | Baylis Medical Company | Nov 1, 2024 | SESE | | [K241414](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K241414.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K240900.md) | HOTWIRE™ RF Guidewire | Atraverse Medical | May 1, 2024 | SESE | | [K232852](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K232852.md) | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | Cross Vascular, Inc. | Oct 12, 2023 | SESE | | [K221528](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K221528.md) | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter | Edwards Lifesciences, LLC | Aug 22, 2022 | SESE | | [K211910](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K211910.md) | Z-6 Atrioseptostomy Catheter | NuMED, Inc. | Jul 19, 2021 | SESE | | [K182399](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K182399.md) | Park Blade Septostomy Catheter | Cook Incorporated | Apr 4, 2019 | SESE | | [K150709](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K150709.md) | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | Jun 17, 2015 | SESE | | [K073326](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K073326.md) | NRG TRANSSEPTAL NEEDLE | Baylis Medical Co., Inc. | May 28, 2008 | SESE | | [K031949](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K031949.md) | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | Baylis Medical Co., Inc. | Dec 10, 2003 | SESE | | [K011557](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K011557.md) | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | NuMED, Inc. | Jul 12, 2001 | SESE | | [K990284](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K990284.md) | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE | Baylis Medical Co., Inc. | Feb 1, 2001 | SESE | | [K001804](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K001804.md) | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER | NuMED, Inc. | Jul 12, 2000 | SESE | | [K860806](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K860806.md) | REGULATED PRESSURE INJECTOR | Target Therapeutics | Mar 31, 1986 | SESE | | [K801031](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF/K801031.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DXF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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