510(k) K192195 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Sterile Dilator
| Applicant | Galt Medical Corp., Garland TX, US |
| Decision | Substantially Equivalent, Sep 26, 2019 |
| Received | Aug 13, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192195
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.