510(k) K191340 ยท KNT Tubes, Gastrointestinal (And Accessories)
CORTRAK* 2 Equilateral Enteral Access System
| Applicant | Avanos Medical, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Jun 4, 2019 |
| Received | May 20, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191340
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2022 | Avanos Medical, Inc. Avanos Cortrak 2 Enteral Access System (EAS) Terminated |
KNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.