510(k) K251499 ยท BTR Tube, Tracheal (W/Wo Connector)
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
| Applicant | William Cook Europe Aps, Bjaeverskov, DK |
| Decision | Substantially Equivalent, Jun 11, 2025 |
| Received | May 15, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251499
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.