510(k) K142298 ยท JOH Tube Tracheostomy And Tube Cuff
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
| Applicant | Covidien, Boulder CO, US |
| Decision | Substantially Equivalent, Feb 13, 2015 |
| Received | Aug 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142298
| 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, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6 Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.