DXE
- Product code
- DXE
- Device name
- Catheter, Embolectomy
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.5150
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 74 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240078 | 2024-08-28 | Edwards Lifesciences, LLC | Fogarty Thru-Lumen Embolectomy Catheter | |
| K241330 | 2024-07-02 | Edwards Lifesciences | Fogarty Fortis Arterial Embolectomy Catheter | |
| K233820 | 2024-05-22 | Edwards Lifesciences | Fogarty Arterial Embolectomy Catheter with Gate Valv… | |
| K233819 | 2024-05-22 | Edwards Lifesciences, LLC | Fogarty Venous Thrombectomy Catheters | |
| K233619 | 2024-05-20 | Edwards Lifesciences | Fogarty Corkscrew Catheters; Fogarty Graft Thrombect… |
Official FDA classification page: DXE
Classification and pathway per current FDA publications. Data from openFDA (CC0).