FDA-Device2022-04-13Class II
Amplatzer Steerable Delivery Sheath
Abbott
Hazard
Instructions for use were updated.
Sold states
OUS distribution only
Affected count
529 units
Manufactured in
5050 Nathan Ln N, Plymouth, MN, United States
Products
Amplatzer Steerable Delivery Sheath
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0895-2022Don't want to check this manually?
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