FDA-Device2019-10-16Class II
Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
Stryker Neurovascular
Hazard
Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
Sold states
OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland
Affected count
190 catheter guides
Manufactured in
47900 Bayside Pkwy, N/A, Fremont, CA, United States
Products
Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0065-2020Don't want to check this manually?
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