Device product
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Z-1085-2024
Product summary
- Firm
- Stryker, Inc.
- Event
- Event 93678
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 63 units
- Official record key
device-enforcement:Z-1085-2024
Official wording
Reason: The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
Code information: UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674
Distribution pattern: US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.
Derived failure modes
-
Unknown
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.