510(k) DEN240017 ยท SCZ Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
ShortCut
| Applicant | Pi-Cardia, Ltd., Rehovot, IL |
| Decision | Unknown, Sep 27, 2024 |
| Received | Apr 17, 2024 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN240017
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.