Data / Medical devices / United States / Altaviz, LLC
Altaviz, LLC: FDA-registered device maker in Irvine, CA, United States, 2 510(k) clearances
Altaviz, LLC is registered with the FDA (registration 3013633270) in Irvine, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 27, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013633270
- Address
- 13766 Alton Parkway Suite 143, Irvine, CA, United States, 92618
- Owner or operator
- Altaviz, LLC (10086745)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 7, 2022
- Registered through
- 2027
- Brand names listed
- Injection Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 27, 2023 | K231261 | Altaviz Needle Kit II | FMI | Substantially Equivalent | Altaviz, LLC | accessdata.fda.gov |
| December 5, 2022 | K222681 | Altaviz Needle Kit | FMI | Substantially Equivalent | Altaviz, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Needle, Hypodermic, Single Lumen
Updated July 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.