510(k) K083641 ยท JOH Tube Tracheostomy And Tube Cuff
BIVONA TRACHEOSTOMY TUBES
| Applicant | Smiths Medical Asd, Inc., Gary IN, US |
| Decision | Substantially Equivalent, Feb 23, 2009 |
| Received | Dec 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083641
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2023 | Smiths Medical ASD Inc. Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile. Open, Classified |
JOH | None listed |
| Aug 28, 2020 | Smiths Medical ASD Inc. Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube
This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single Terminated |
JOH | None listed |
| Feb 9, 2017 | Smiths Medical ASD Inc. Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035. Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.