510(k) K810106 ยท BTO Tube, Tracheostomy (W/Wo Connector)
SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE
| Applicant | Shiley, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 2, 1981 |
| Received | Jan 16, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810106
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Single Cannula Cuffed Tracheostomy Tube, 5 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstruction Terminated |
BTO | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Single Cannula Cuffed Tracheostomy Tube, 6 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstruction Terminated |
BTO | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Single Cannula Cuffed Tracheostomy Tube, 7 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstruction Terminated |
BTO | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Single Cannula Cuffed Tracheostomy Tube, 8 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstruction Terminated |
BTO | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Single Cannula Cuffed Tracheostomy Tube, 9 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstruction Terminated |
BTO | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Single Cannula Cuffed Tracheostomy Tube, 10 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructio Terminated |
BTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.