510(k) K003315 ยท JOH Tube Tracheostomy And Tube Cuff
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
| Applicant | Mallinckrodt, Inc., St. Charles MO, US |
| Decision | Substantially Equivalent, Nov 8, 2000 |
| Received | Oct 23, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003315
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2004 | Nellcor Puritan Bennett Shiley TracheoSoft XLT Extended Length Tracheostomy tube;
Model Numbers:
72110-050, size 5, Proximal Extension, Uncuffed;
72110-060, size 6, Proximal Extension, Uncuffed;
72110-070, size 7, Proximal Terminated |
--- | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.