510(k) K201472 ยท LRC Instrument, Ent Manual Surgical
VenSure Balloon Device, VenSure Nav Balloon Device
| Applicant | Fiagon GmbH, Hennigsdorf, DE |
| Decision | Substantially Equivalent, Aug 26, 2020 |
| Received | Jun 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201472
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.