SHR
- Product code
- SHR
- Device name
- Device For Open Surgical Explant Of Endovascular Prostheses
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4520
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| DEN250033 | 2026-04-17 | Hjarta Care, LLC | XplantR Explant Tool | — |
Official FDA classification page: SHR
Classification and pathway per current FDA publications. Data from openFDA (CC0).