FDA product code DXE: Catheter, Embolectomy
DXE is the FDA product code for catheter, embolectomy. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel. FDA has cleared 74 510(k) submissions under DXE, 6 in the last five years, from 41 different applicants. The average 510(k) review took 148 days (median 134); 164 days on average over the last three years. FDA has posted 57 recalls for DXE devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Embolectomy |
| Device class | Class II |
| Regulation | 21 CFR 870.5150 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 246 |
| 2020 | 1 | 190 |
| 2021 | 1 | 410 |
| 2022 | 1 | 56 |
| 2024 | 5 | 164 |
Compare with all 510(k) review times · Search every DXE clearance
Top DXE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shiley, Inc. | 5 | 1989-10-12 |
| Vascutech, Inc. | 4 | 2000-03-08 |
| Lucas Medical, Inc. | 4 | 1997-11-19 |
| Ideas For Medicine, Inc. | 4 | 1997-01-13 |
| Cathlab Corp. | 4 | 1991-02-25 |
36 more applicants have DXE clearances. See the full list in Caduvo.
Most recent DXE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240078 | Edwards Lifesciences, LLC | Fogarty Thru-Lumen Embolectomy Catheter | 2024-08-28 | 230 |
| K241330 | Edwards Lifesciences | Fogarty Fortis Arterial Embolectomy Catheter | 2024-07-02 | 53 |
| K233820 | Edwards Lifesciences | Fogarty Arterial Embolectomy Catheter with Gate Valve | 2024-05-22 | 173 |
| K233819 | Edwards Lifesciences, LLC | Fogarty Venous Thrombectomy Catheters | 2024-05-22 | 173 |
| K233619 | Edwards Lifesciences | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | 2024-05-20 | 189 |
Recalls for DXE devices
57 product recalls in 30 recall events; 7 initiated in the last five years and 8 still open. Most recent: 2026-04-21.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 4 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code DXE?
DXE is the FDA product code for catheter, embolectomy. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel.
What device class is DXE?
Class II, regulation 21 CFR 870.5150. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXE?
Across 74 cleared submissions the average was 148 days from receipt to decision (median 134).
Which companies have the most DXE clearances?
Shiley, Inc. (5); Vascutech, Inc. (4); Lucas Medical, Inc. (4); Ideas For Medicine, Inc. (4); Cathlab Corp. (4).
Have DXE devices been recalled?
Yes: 57 product recalls across 30 recall events; the most recent began 2026-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code DXE
- Run a recall and safety report across every DXE manufacturer
- Watch product code DXE 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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