FDA-Device2014-12-10Class II
GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable
Stryker Neurovascular
Hazard
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Sold states
US Distribution to the states of: VA, NH, OH and TX.
Affected count
1
Manufactured in
47900 Bayside Pkwy, N/A, Fremont, CA, United States
Products
GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0478-2015Don't want to check this manually?
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