510(k) Report

Devices descending from K992454

6 later devices reach Venaflow System, Model 30A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121145Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical…Renu Medical, Inc.20120—
+1K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC20100—
+1K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical20060—
+1K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc.20063—
+2K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc.20091—
+3K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC20100—