FDA-Device2025-03-19Class II
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Cordis US Corp
Hazard
Catheter manufactured at the incorrect length.
Sold states
US: WA OUS: Japan
Affected count
12 units
Manufactured in
14201 Nw 60th Ave, Miami Lakes, FL, United States
Products
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2025Don't want to check this manually?
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