510(k) K030381 ยท BTO Tube, Tracheostomy (W/Wo Connector)
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
| Applicant | Portex , Ltd., England Ct21 6db, GB |
| Decision | Substantially Equivalent, Aug 27, 2003 |
| Received | Feb 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030381
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2019 | Smiths Medical ASD Inc. Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part,
Product Usage:
The Portex Blue Line Ultra Tracheostomy Tubes are indicated for a Terminated |
BTO | None listed |
| Apr 6, 2006 | Smiths Medical ASD, Inc. Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula
REF 100/858/080 Terminated |
BTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.