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/productcode/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](/device/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](/device/K260292.md) | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical | Feb 27, 2026 | SESE |
| [K252419](/device/K252419.md) | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical, Inc. | Aug 27, 2025 | SESE |
| [K251007](/device/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](/device/K243193.md) | Cross Wise™ Multi-Use RF Adapter Cable | Circa Scientific, Inc. | Nov 26, 2024 | SESE |
| [K242076](/device/K242076.md) | VersaCross™ RF Wire | Baylis Medical Company | Nov 1, 2024 | SESE |
| [K241414](/device/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](/device/K240900.md) | HOTWIRE™ RF Guidewire | Atraverse Medical | May 1, 2024 | SESE |
| [K232852](/device/K232852.md) | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | Cross Vascular, Inc. | Oct 12, 2023 | SESE |
| [K221528](/device/K221528.md) | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter | Edwards Lifesciences, LLC | Aug 22, 2022 | SESE |
| [K211910](/device/K211910.md) | Z-6 Atrioseptostomy Catheter | NuMED, Inc. | Jul 19, 2021 | SESE |
| [K182399](/device/K182399.md) | Park Blade Septostomy Catheter | Cook Incorporated | Apr 4, 2019 | SESE |
| [K150709](/device/K150709.md) | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | Jun 17, 2015 | SESE |
| [K073326](/device/K073326.md) | NRG TRANSSEPTAL NEEDLE | Baylis Medical Co., Inc. | May 28, 2008 | SESE |
| [K031949](/device/K031949.md) | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | Baylis Medical Co., Inc. | Dec 10, 2003 | SESE |
| [K011557](/device/K011557.md) | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | NuMED, Inc. | Jul 12, 2001 | SESE |
| [K990284](/device/K990284.md) | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE | Baylis Medical Co., Inc. | Feb 1, 2001 | SESE |
| [K001804](/device/K001804.md) | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER | NuMED, Inc. | Jul 12, 2000 | SESE |
| [K860806](/device/K860806.md) | REGULATED PRESSURE INJECTOR | Target Therapeutics | Mar 31, 1986 | SESE |
| [K801031](/device/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/productcode/DXF](https://fda.innolitics.com/productcode/DXF)

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