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

About This 510(k) Submission

K230028 is an FDA 510(k) clearance for the 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, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on April 3, 2023, 89 days after receiving the submission on January 4, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.