SHR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device For Open Surgical Explant Of Endovascular Prostheses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4520
- Medical specialty
- Cardiovascular
- FDA definition
- This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| XplantR Explant Tool (DEN250033) | Hjarta Care, LLC | 2026-04-17 |
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Every clearance here is in the API, with alerts when new ones post.