Data / Medical devices / United States / 410 Medical Inc.
410 Medical Inc.: FDA-registered device maker in Durham, NC, United States, 2 510(k) clearances
410 Medical Inc. is registered with the FDA (registration 3012969104) in Durham, NC, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 20, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012969104
- Address
- 68 TW Alexander Dr, Durham, NC, United States, 27713
- Owner or operator
- 410 Medical Inc. (10052654)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- September 2, 2016
- Registered through
- 2026
- Brand names listed
- LifeFlow, LifeFlow Blood System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | 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 |
|---|---|---|---|---|---|---|
| May 20, 2020 | K191362 | LifeFlow Blood System | FPA | Substantially Equivalent | 410 Medical, Inc. | accessdata.fda.gov |
| August 25, 2016 | K153731 | LifeFlow Rapid Infusion Device (LifeFlow Device) | FPA | Substantially Equivalent | 410 Medical Innovation, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 20, 2020. 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.