510(k) K934465 ยท BTR Tube, Tracheal (W/Wo Connector)
DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
| Applicant | Smiths Industries Medical Systems, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Jan 14, 1994 |
| Received | Sep 13, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tubes
Catalog Number: 519000 Terminated |
BTO | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Lo-Profile Tracheostomy Tube Decannulation Cap
Catalog Number: 582000 Terminated |
BTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.