510(k) K922665 ยท JOH Tube Tracheostomy And Tube Cuff
BIVONA HYPERFLEX TRACHEOSTOMY TUBE
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Jan 7, 1993 |
| Received | Jun 1, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922665
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2006 | Smiths Medical ASD, Inc. Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60. Terminated |
JOH | None listed |
| Jan 18, 2006 | Smiths Medical ASD, Inc. Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80. Terminated |
JOH | None listed |
| Jan 18, 2006 | Smiths Medical ASD, Inc. Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 130 mm; REF 67HA80. Terminated |
JOH | None listed |
| Jan 6, 2006 | Smiths Medical ASD, Inc. Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70. Terminated |
BTO | None listed |
| Jun 12, 2003 | Portex, Inc Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40. Terminated |
KOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.