510(k) K091591 ยท BTR Tube, Tracheal (W/Wo Connector)
FLEXICARE MEDICAL ENDOTRACHEAL TUBES
| Applicant | Flexicare Medical, Ltd., Mid Glamorgan, GB |
| Decision | Substantially Equivalent, Jun 17, 2009 |
| Received | Jun 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2020 | Flexicare Medical Ltd. ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5
*Note: product list updated per 12/23/2020 letter to customers Terminated |
BTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.