FDA-Device2014-12-17Class II
Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended 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 vascular systems.
Concentric Medical Inc
Hazard
Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.
Sold states
US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.
Affected count
87 units
Manufactured in
301 E Evelyn Ave, N/A, Mountain View, CA, United States
Products
Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended 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 vascular systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0525-2015Don't want to check this manually?
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