510(k) K200379 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Super Sheath
| Applicant | Togo Medikit Co., Ltd., Hyuga City, JP |
| Decision | Substantially Equivalent, Mar 19, 2020 |
| Received | Feb 18, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200379
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.