510(k) K913859 ยท JOH Tube Tracheostomy And Tube Cuff
BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Jan 30, 1992 |
| Received | Aug 27, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913859
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2007 | Smiths Medical ASD, Inc. Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185. Terminated |
JOH | None listed |
| Oct 19, 2006 | Smiths Medical ASD, Inc. Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160. Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.