510(k) Report

Devices descending from K933586

52 later devices reach Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100645Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceMedtronic, Inc.20124—
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+1K06344115.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32…Spire Biomedical, Inc.2007048
+1K06343115.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28…Spire Biomedical, Inc.2007048
+1K06015515.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated TipsSpire Biomedical, Inc.2006347
+1K051997Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp.2005251
+1K033800Capiox Cardiotomy ReservoirTerumo Cardiovascular Systems Corporation20040—
+1K022115Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell ReservoirTerumo Corp.200226—
+2K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with…Medtronic, Inc.20170—
+2K160091Temperature Probe, Affinity Temperature ProbeMedtronic, Inc.20160—
+2K141233Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceMedtronic, Inc.20141—
+2K130493Capiox RX05 Hollow Fiber Oxygenator/ReservoirTerumo Corporation20130—
+2K123448Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock…Medtronic, Inc.20120—
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+2K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG201112
+2K102464Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with…Maquet Cardiopulmonary, AG20116Class I
+2K090689Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline…Maquet Cardiopulmonary, AG200995
+2K090449Medos Hilite Infant Oxygenator, Model 1000, 800 LTGish Biomedical, Inc.20091—
+2K090450Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LTGish Biomedical, Inc.20092—
+2K091062Medos Hilite Infant Reservoir, Model MVC 0730Gish Biomedical, Inc.20090—
+2K082321Terumo Rocsafe Hybrid Perfusion SystemTerumo Cardiovascular Systems Corp.20090—
+2K073093Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24…Spire Biomedical, Inc.20080—
+2K071572Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial FilterTerumo Corp.20071—
+2K071494Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial FilterTerumo Corp.2007712
+2K062381Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp.200692
+3K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+3K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.L20240—
+3K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG20140Class I
+3K140774Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation20145—
+3K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc.20142—
+3K140181Medos Hilite Infant OxygenatorMedos Medizintechnik AG20140—
+3K140177Medos Hilite OxygenatorMedos Medizintechnik AG20140—
+3K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG201341
+3K130333Capix RX Hollow Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp.20137—
+3K130520Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp.20136—
+3K130280Capiox FX Hollow Fiber Oxygenator W/ ReservoirTerumo Corporation20130—
+3K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+3K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG200983
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+4K153213Capiox RX Hollow Fiber Oxygenator with/without Hardshell ReservoirTerumo Cardiovascular Systems Corporation20150—
+4K151791Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir…Terumo Cardiovascular Systems Corporation201522
+4K151389Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell…Terumo Cardiovascular Systems Corporation20151—
+4K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG201522
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+4K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—
+5K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L20250—
+5K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+5K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19…Terumo Cardiovascular Systems Corporation201805
+5K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19…Terumo Cardiovascular Systems Corporation20180—
+5K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+6K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—