510(k) Report

Devices descending from K781357

15 later devices reach T.E.D. Sequential Compression Sleeves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140813Reprocessed Kendall SCD Express Compression SleevesCovidien20142—
+1K051805Kendall SCD Sleeves (Extra Large Knee, Extra Large Thigh), Kendall SCD Lexpres Sleeves…Tyco Healthcare/Kendall20054—
+1K040649Kendall SCD Express Kambia Thigh Length Tearaway SleeveTyco Healthcare20045—
+1K012597Sterilmed Reprocessed Compression SleevesSterilmed, Inc.20021—
+1K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc.200136
+2K161105Reprocessed Compression GarmentsCovidien20161—
+2K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest…Midwest Reprocessing Center, LLC20100—
+2K100909Reprocessed Compression SleevesAscent Healthcare Solutions201001
+2K100306Kendall SCD Sequential Compression Comfort SleevesCovidien20100—
+2K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical20060—
+2K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc.200611
+2K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc.20063—
+3K163620Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort…Covidien20170—
+3K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc.20091—
+4K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC20100—