510(k) K964056 ยท JOH Tube Tracheostomy And Tube Cuff
RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE
| Applicant | Rusch Intl., Jeffrey NH, US |
| Decision | Substantially Equivalent, Oct 10, 1997 |
| Received | Oct 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2016 | Teleflex Medical Willy Rusch GmbH Tracheostomy Tube Set
Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short te Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.