Data / Medical devices / France / Medtronic Fabrication S.A.S.
Medtronic Fabrication S.A.S.: FDA-registered device maker in FOURMIES Nord, France, 3 510(k) clearances
Medtronic Fabrication S.A.S. is registered with the FDA (registration 9611350) in FOURMIES Nord, France. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated August 8, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9611350
- FEI number
- 1000241540
- Address
- 103 Route D Anor, FOURMIES Nord, France, 59610
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- February 4, 2009
- Registered through
- 2027
- Brand names listed
- Streamline Temporary Pacing Leads, Streamline Temporary Pacing Wire, Temporary Pacing Lead System, Model 6416
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Pacemaker, Temporary | LDF | 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 |
|---|---|---|---|---|---|---|
| August 8, 2019 | K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead | LDF | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 25, 2017 | K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead | LDF | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 26, 1998 | K973360 | MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD | LDF | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
Compare with other makers
Updated August 8, 2019. 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.