FDA-Device2022-09-14Class II
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
BALT USA, LLC
Hazard
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Sold states
U.S.: AZ and FL O.U.S.: None
Affected count
4 devices
Manufactured in
29 Parker Ste 100, N/A, Irvine, CA, United States
Products
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1680-2022Don't want to check this manually?
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