510(k) K914088 ยท JOH Tube Tracheostomy And Tube Cuff
BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Oct 23, 1991 |
| Received | Sep 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Dec 23, 2005 | Smiths Medical ASD, Inc. Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040. Terminated |
BTO | None listed |
| Jun 25, 2005 | Smiths Medical ASD, Inc. Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035. Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.