FDA-Device2016-02-10Class II
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
Bard Peripheral Vascular Inc
Hazard
IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
Sold states
Distributed to CA only.
Affected count
1,183 units
Manufactured in
1625 W 3rd St, N/A, Tempe, AZ, United States
Products
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0737-2016Don't want to check this manually?
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