FDA-Device2022-10-05Class II
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
Angiodynamics, Inc.
Hazard
OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention
Sold states
US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.
Affected count
40 units
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1819-2022Don't want to check this manually?
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