510(k) K222681 ยท FMI Needle, Hypodermic, Single Lumen
Altaviz Needle Kit
| Applicant | Altaviz, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 5, 2022 |
| Received | Sep 6, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222681
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2023 | Apellis Pharmaceuticals, Inc. Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 m Open, Classified |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.