FDA-Device2014-12-10Class II
Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
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 unit
Manufactured in
47900 Bayside Pkwy, N/A, Fremont, CA, United States
Products
Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0482-2015Don't want to check this manually?
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