510(k) Report

Devices descending from K061743

3 later devices reach Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090534Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG20092—
+2K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG201112
+3K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG20140Class I