510(k) DEN250033 ยท SHR Device For Open Surgical Explant Of Endovascular Prostheses
XplantR Explant Tool
| Applicant | Hjarta Care, LLC, Waukesha WI, US |
| Decision | Unknown, Apr 17, 2026 |
| Received | Aug 7, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250033
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.