FDA-Device2015-10-21Class II
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
Concentric Medical Inc
Hazard
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Sold states
US Distribution to one location in KY.
Affected count
1
Manufactured in
301 E Evelyn Ave, N/A, Mountain View, CA, United States
Products
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0116-2016Don't want to check this manually?
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