510(k) K894614 ยท JOH Tube Tracheostomy And Tube Cuff
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Oct 13, 1989 |
| Received | Jul 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894614
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2005 | Smiths Medical ASD, Inc. Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70. 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.