510(k) K211679 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Xtractor device
| Applicant | Xcardia Innovation , Ltd., Rehovot, IL |
| Decision | Substantially Equivalent, Feb 17, 2022 |
| Received | Jun 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211679
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.