Data / Medical devices / United States / Lineus Medical
Lineus Medical: FDA-registered device maker in Fayetteville, AR, United States, 4 510(k) clearances
Lineus Medical is registered with the FDA (registration 3019511659) in Fayetteville, AR, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated September 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019511659
- Address
- 179 North Church Avenue Suite 202, Fayetteville, AR, United States, 72701
- Owner or operator
- Lineus Medical (10082114)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 16, 2021
- Registered through
- 2026
- Brand names listed
- SafeBreak Vascular
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intravenous Catheter Force-Activated Separation Device. | QOI | 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 |
|---|---|---|---|---|---|---|
| September 29, 2023 | K231957 | SafeBreak® Vascular | QOI | Substantially Equivalent | Lineus Medical | accessdata.fda.gov |
| May 19, 2023 | K223486 | SafeBreak® Vascular | QOI | Substantially Equivalent | Lineus Medical | accessdata.fda.gov |
| October 16, 2022 | K222791 | SafeBreak Vascular | QOI | Substantially Equivalent | Lineus Medical, LLC | accessdata.fda.gov |
| May 27, 2021 | DEN190043 | SafeBreak Vascular | QOI | Unknown | Site Saver, Inc. D/B/A Lineus Medical | accessdata.fda.gov |
Compare with other makers
Updated September 29, 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.