Data / Medical devices / France / Cair LGL
Cair LGL: FDA-registered device maker in Saint Laurent de Chamousset Rhone, France, 4 510(k) clearances
Cair LGL is registered with the FDA (registration 3014498869) in Saint Laurent de Chamousset Rhone, France. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 1, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014498869
- Address
- 60, Route de Saint Bonnet ZA La Croix grand borne, Saint Laurent de Chamousset Rhone, France, 69930
- Owner or operator
- Cair LGL (10059419)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 10, 2019
- Registered through
- 2026
- Brand names listed
- Carefusion NeutraClear Needle-free connector, Carefusion NeutraClear multi-fuse Extension Set with need-free connector(s), DCX Disposable Cassette, Guerbet 150cm Straight Extension/Injection Line for CT & MRI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| System, Perfusion, Kidney | KDN | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| September 1, 2017 | K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000) | FPA | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
| August 15, 2017 | K171118 | Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) | FPA | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
| July 31, 2017 | K171132 | Carefusion NeutraClear Needle-free connector | FPA | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
| March 20, 2014 | K133073 | CAIR DRIVE, NEUTRACLEAR | FPA | Substantially Equivalent | Cair Lgl | accessdata.fda.gov |
Compare with other makers
Updated September 1, 2017. 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.