FDA-Device2022-05-11Class II
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
Baxter Healthcare Corporation
Hazard
There is a potential for foreign matter.
Sold states
Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom
Affected count
300 devices
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1019-2022Don't want to check this manually?
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