510(k) K935842 ยท BTR Tube, Tracheal (W/Wo Connector)
RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE
| Applicant | Rusch, Inc., Duluth GA, US |
| Decision | Substantially Equivalent, May 23, 1995 |
| Received | Dec 7, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2020 | TELEFLEX MEDICAL INC RUSCH LASERTUBE (Rubber), RES 102004, Sizes:
a) I.D. mm 4,0, Product Code 102004-000040
b) I.D. mm 5,0, Product Code 102004-000050
c) I.D. mm 6,0, Product Code 102004-000060
d) I.D. mm 7,0, Product Co Terminated |
BTR | None listed |
| Apr 1, 2019 | Teleflex Medical RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0 Terminated |
BTR | None listed |
| Apr 1, 2019 | Teleflex Medical RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0 Terminated |
BTR | None listed |
| Apr 1, 2019 | Teleflex Medical RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0 Terminated |
BTR | None listed |
| Apr 1, 2019 | Teleflex Medical RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0 Terminated |
BTR | None listed |
| Apr 1, 2019 | Teleflex Medical RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0 Terminated |
BTR | None listed |
| Jun 23, 2014 | Teleflex Medical RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH.
A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and use Terminated |
BTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.