DXFClass II
Catheter, Septostomy
21 CFR 870.5175 / Cardiovascular
DXF is the FDA product code for Catheter, Septostomy, a class II device type, regulated under 21 CFR 870.5175. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and 10 recalls.
Classification record
- Product code
- DXF
- Device name
- Catheter, Septostomy
- Regulation
- 21 CFR 870.5175
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 21
- Ingested recalls
- 10
Clearances, product code DXF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1986 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2003 | 1 |
| 2008 | 1 |
| 2015 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 4 |
| 2025 | 2 |
| 2026 | 3 |
Applicants with the most clearances
Product code DXF| Applicant | Clearances |
|---|---|
| Baylis Medical Co., Inc. | 5 |
| Atraverse Medical | 3 |
| CIRCA Scientific, Inc. | 3 |
| Numed Inc | 3 |
| Cook Incorporated | 1 |
| Cook, Inc. | 1 |
| Cross Vascular, Inc. | 1 |
| Edwards Lifesciences LLC | 1 |
| ElectroWire Medical | 1 |
| Pressure Products Medical Device Manufacturing LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Accumedix, Inc.
- Atraverse Medical
- Baylis Medical Technologies Inc.
- Boston Scientific Corporation
- CIRCA Scientific, Inc.
- Cook Incorporated
- Edwards Lifesciences LLC
- Electrowire Corporation dba Electrowire Medical
- Heraeus Medical Components, LLC
- Isomedix Operations Inc
- Lake Region Medical
- LYNX Medical Pennsylvania
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.