510(k) K230028

Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly by Cardinal Health200, LLC — Product Code JOW

K230028 is an FDA 510(k) premarket notification submitted by Cardinal Health200, LLC for the device "Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly". The FDA issued a decision of Substantially Equivalent on April 3, 2023. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Cardinal Health200, LLC has at least 10 other 510(k) clearances on record.