510(k) K925615 ยท CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE
| Applicant | Sorin Biomedica, Fiat, USA, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 26, 1993 |
| Received | Nov 6, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, MPDC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, p Terminated |
JOH | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, M4.0PDC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions Terminated |
JOH | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, M5.5PDC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions Terminated |
JOH | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, MPLC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions, p Terminated |
JOH | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Specialized Tracheostomy Tube, M5.5PLC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructions Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.