Data / Medical devices / United States / Koag International LLC
Koag International LLC: FDA-registered device maker in Vonore, TN, United States, 1 510(k) clearance
Koag International LLC is registered with the FDA (registration 3020664666) in Vonore, TN, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020664666
- Address
- 790 Rarity Bay Parkway, Vonore, TN, United States, 37885
- Owner or operator
- KOAG International LLC (10061465)
- Roles
- Specification developer
- First device listed
- October 7, 2021
- Registered through
- 2026
- Brand names listed
- Vascette HP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Closure, Wound, Adhesive | MGO | 1 | Specification developer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | 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 29, 2022 | K220566 | Vascette HP (hemostatic pad) | QSY | Substantially Equivalent | Koag, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Closure, Wound, Adhesive
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Updated July 29, 2022. 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.