Device product
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Z-1680-2022
Product summary
- Firm
- BALT USA, LLC
- Event
- Event 90724
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 devices
- Official record key
device-enforcement:Z-1680-2022
Official wording
Reason: 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.
Code information: Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470
Distribution pattern: U.S.: AZ and FL O.U.S.: None
Derived failure modes
-
Unknown
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.