510(k) K955680 ยท JOH Tube Tracheostomy And Tube Cuff
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED
| Applicant | Mallinckrodt Medical, St Louis MO, US |
| Decision | Substantially Equivalent, Mar 13, 1996 |
| Received | Dec 14, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955680
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Cuffed Pediatric Tracheostomy Tube, 4.0 PDC, Assembled 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 Cuffed Pediatric Tracheostomy Tube, 4.5 PDC, Assembled 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 Cuffed Pediatric Tracheostomy Tube, 5.0 PDC, Assembled 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 Cuffed Pediatric Tracheostomy Tube, 5.5 PDC, Assembled 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 Cuffed Long Pediatric Tracheostomy Tube, 5.0 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructi Terminated |
JOH | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.5 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructi Terminated |
JOH | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.0 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructi Terminated |
JOH | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.5 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstructi Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.