510(k) Report

Devices descending from K061072

10 later devices reach Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072583Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30Maquet Cardiopulmonary, AG20082—
+1K070605Jostra Venous Softbag Reservoirs with and Without Safeline CoatingMaquet Cardiopulmonary, AG20081—
+1K061832Jostra HLM Tubing Sets with Safeline CoatingMaquet Cardiopulmonary, AG20060—
+1K061743Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum…Maquet Cardiopulmonary, AG20063—
+2K090534Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG20092—
+2K090690Venous Softbag Reservoirs with Softline CoatingMaquet Cardiopulmonary, AG20090—
+2K090555Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Maquet Cardiopulmonary, AG200911
+3K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+3K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG201112
+4K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG20140Class I