510(k) Report

Devices descending from K934847

10 later devices reach Ngbcd & Ngbcdp Cardioplegia Delivery Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…Sorin Group Italia S.R.L.20250—
+1K021830Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia SystemCobe Cardiovascular, Inc.20020—
+1K012898Modification to: CSC14 Blood Cardioplegia SystemCobe Cardiovascular, Inc.20016—
+1K982467Capiox CardioplegiaTerumo Medical Corp.19990—
+2K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L20222—
+2K072583Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30Maquet Cardiopulmonary, AG20082—
+3K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L202212
+3K090555Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Maquet Cardiopulmonary, AG200911
+4K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.202302
+4K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012