FDA product code DXF: Catheter, Septostomy
DXF is the FDA product code for catheter, septostomy. It is a Class II device, regulated under 21 CFR 870.5175 and reviewed by the Cardiovascular panel. FDA has cleared 21 510(k) submissions under DXF, 11 in the last five years, from 14 different applicants. The average 510(k) review took 108 days (median 57); 55 days on average over the last three years. FDA has posted 10 recalls for DXF devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Septostomy |
| Device class | Class II |
| Regulation | 21 CFR 870.5175 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 212 |
| 2021 | 1 | 28 |
| 2022 | 1 | 88 |
| 2023 | 1 | 28 |
| 2024 | 4 | 82 |
| 2025 | 2 | 28 |
| 2026 | 3 | 55 |
Compare with all 510(k) review times · Search every DXF clearance
Top DXF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Circa Scientific, Inc. | 3 | 2025-05-01 |
| NuMED, Inc. | 3 | 2021-07-19 |
| Baylis Medical Co., Inc. | 3 | 2008-05-28 |
| Atraverse Medical | 2 | 2026-02-27 |
| ElectroWire Medical | 1 | 2026-06-26 |
9 more applicants have DXF clearances. See the full list in Caduvo.
Most recent DXF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261745 | ElectroWire Medical | LightningWire Transseptal Puncture System (TPS) | 2026-06-26 | 30 |
| K253799 | Pressure Products Medical Device Manufacturing, LLC | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | 2026-03-13 | 105 |
| K260292 | Atraverse Medical | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | 2026-02-27 | 29 |
| K252419 | Atraverse Medical, Inc. | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | 2025-08-27 | 26 |
| K251007 | Circa Scientific, Inc. | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | 2025-05-01 | 30 |
Recalls for DXF devices
10 product recalls in 4 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-06-10.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2020 | 3 |
| 2025 | 4 |
Frequently asked questions
What is FDA product code DXF?
DXF is the FDA product code for catheter, septostomy. It is a Class II device, regulated under 21 CFR 870.5175 and reviewed by the Cardiovascular panel.
What device class is DXF?
Class II, regulation 21 CFR 870.5175. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXF?
Across 21 cleared submissions the average was 108 days from receipt to decision (median 57).
Which companies have the most DXF clearances?
Circa Scientific, Inc. (3); NuMED, Inc. (3); Baylis Medical Co., Inc. (3); Atraverse Medical (2); ElectroWire Medical (1).
Have DXF devices been recalled?
Yes: 10 product recalls across 4 recall events; the most recent began 2025-06-10.
Next steps
- Run an FDA pathway report with predicate devices for product code DXF
- Run a recall and safety report across every DXF manufacturer
- Watch product code DXF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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