510(k) K945513 ยท JOH Tube Tracheostomy And Tube Cuff
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
| Applicant | Mallinckrodt Medical, St Louis MO, US |
| Decision | Substantially Equivalent, Jan 13, 1995 |
| Received | Nov 9, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945513
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2009 | Covidien Limited Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The product is provided as Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.