510(k) K944178 ยท JOH Tube Tracheostomy And Tube Cuff
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Oct 27, 1994 |
| Received | Aug 26, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944178
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2021 | Smiths Medical ASD Inc. Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to pro Terminated |
JOH | None listed |
| Dec 15, 2020 | Smiths Medical ASD Inc. PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45 Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.