510(k) K984528 ยท BTR Tube, Tracheal (W/Wo Connector)
PARKER FLEX-TIP TRACHEAL TUBE
| Applicant | Parker Medical Assoc., Englewood CO, US |
| Decision | Substantially Equivalent, Jul 15, 1999 |
| Received | Dec 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984528
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2017 | Parker Medical Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1,
H-PFTDL-41-1.
Terminated |
CBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.