510(k) K963732 ยท JOH Tube Tracheostomy And Tube Cuff
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
| Applicant | Mallinckrodt Medical, St Louis MO, US |
| Decision | Substantially Equivalent, Jun 26, 1997 |
| Received | Sep 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963732
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Percutaneous Dual Cannula Tracheostomy Tube, 6 PERC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstru Terminated |
JOH | None listed |
| May 6, 2010 | Nellcor Puritan Bennett Inc. (dba Covidien Ltd) Shiley Percutaneous Dual Cannula Tracheostomy Tube, 8 PERC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.
Intended for bypass of upper airway obstru Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.