510(k) K203749 ยท CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
| Applicant | Ambu A/S, Ballerup, DK |
| Decision | Substantially Equivalent, May 3, 2021 |
| Received | Dec 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203749
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2024 | Ambu Inc. Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000) Open, Classified |
CBI | None listed |
| Jun 3, 2022 | Ambu Inc. Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000,
412371000,
412391000,
412411000 Open, Classified |
CBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.