FDA-Device2022-08-10Class II
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Boston Scientific Corporation
Hazard
Product may be mislabeled.
Sold states
US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Affected count
10 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1491-2022Don't want to check this manually?
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