Data / Medical devices / United States / HemoSonics, LLC (SC)
HemoSonics, LLC (SC): FDA-registered device maker in Durham, NC, United States, 3 510(k) clearances
HemoSonics, LLC (SC) is registered with the FDA (registration 3014240198) in Durham, NC, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated November 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014240198
- Address
- 4020 Stirrup Creek Drive Suite 105, Durham, NC, United States, 27703
- Owner or operator
- HemoSonics, LLC (10057901)
- Roles
- Manufacturer
- First device listed
- April 15, 2019
- Registered through
- 2026
- Brand names listed
- QStat Cartridge, Quantra Desktop Remote Viewer, Quantra Hemostasis Analyzer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties | QFR | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 29, 2022 | K213917 | QStat Cartridge | QFR | Substantially Equivalent | Hemosonics, LLC | accessdata.fda.gov |
| August 21, 2020 | K201513 | Quantra QPlus System | QFR | Substantially Equivalent | Hemosonics, LLC | accessdata.fda.gov |
| March 12, 2019 | DEN180017 | Quantra Hemostasis Analyzer, QPlus Cartridge | QFR | Unknown | Hemosonics, LLC | accessdata.fda.gov |
Updated November 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.