510(k) K922749 ยท BTO Tube, Tracheostomy (W/Wo Connector)
LOW PROFILE TRACHEOSTOMY TUBE
| Applicant | Concord/Portex, Keene NH, US |
| Decision | Substantially Equivalent, Sep 2, 1992 |
| Received | Jun 8, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922749
| 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 |
| Jul 23, 2003 | Portex Inc. Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm
Catalog Number: 593090 Terminated |
BTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.