510(k) K030787 ยท JOH Tube Tracheostomy And Tube Cuff
SHILEY FLEXTRA TRACHEOSTOMY TUBE
| Applicant | Nellcor Puritan Bennett, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Nov 14, 2003 |
| Received | Mar 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030787
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2005 | Nellcor Puritan Bennett Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube,
Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed;
358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 3 Terminated |
JDH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.