510(k) K122531 ยท JOH Tube Tracheostomy And Tube Cuff
SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
| Applicant | Covidien, Boulder CO, US |
| Decision | Substantially Equivalent, Oct 9, 2012 |
| Received | Aug 20, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122531
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2015 | Covidien LP (formerly Nellcor Puritan Bennett Inc.) Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff.
Intended for use in providing tracheal access for airway managements. Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.