510(k) Report

Devices descending from K980600

73 later devices reach D903 Avant Adult Hollow Fiber Oxygenator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033323D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow…Dideco S.P.A.2004281
+1K020351D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A.200272—
+2K121536Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell ReservoirSorin Group Italia S.R.L.201210—
+2K121229Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell Venous/CardiotomySorin Group Italia S.R.L.201212—
+2K083021Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L.200842
+2K043323D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirDideco S.R.L.2005171
+2K031223Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A.200332—
+2K030462Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc.200391
+2K022450Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter…Dideco S.P.A.200235—
+2K020997Apex PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorDideco S.P.A.200252
+3K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L20204—
+3K190650Revolution Centrifugal Blood PumpSorin Group Italia S.R.L.20190—
+3K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated…Sorin Group Italia S.R.L.20185—
+3K150489EOS PMP, EOS PMP IntegratedSorin Group Italia S.R.L.20155—
+3K130433Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow…Sorin Group Italia S.R.L.201321
+3K122844Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L.20123—
+3K122254Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirSorin Group Italia S.R.L.20126—
+3K120185Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L.20128—
+3K092895Apex HP M Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L.200931
+3K073380Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and…Sorin Group Italia S.R.L.2008271
+3K061527Card 43 Cardiotomy Reservoir with Phosphorylcholine CoatingSorin Group Italia S.R.L.20060—
+3K050890Ecc.O SystemDideco S.R.L.20051—
+3K033714MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with Phosphorylcholine CoatingDideco S.P.A.20030—
+3K032040Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump…Dideco S.P.A.200321
+3K030154Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket…Dideco S.P.A.20033—
+4K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L20260—
+4K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.20250—
+4K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…Eurosets S.R.L20250—
+4K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.20240—
+4K212341Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum…Qura S.R.L20220—
+4K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L20222—
+4K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+4K211495Eos PMPSorin Group Italia S.R.L.20210—
+4K202206AMG PMP PediatricEurosets S.R.L20211—
+4K201642Paragon Adult Maxi PMP Oxygenator with Tubing PackChalice Medical, Ltd.20201—
+4K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L20203—
+4K201916Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M…Sorin Group Italia S.R.L.20200—
+4K200683INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow…Sorin Group Italia S.R.L.20200—
+4K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)Chalice Medical, Ltd.20200—
+4K130209Inspire 6 Hollow Fiber Oxygenator with Integrated Hardhell Reservoir, Inspire 6F Hollow…Sorin Group Italia S.R.L.201301
+4K121909Inspire 6 Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy…Sorin Group Italia S.R.L.20120—
+4K102109Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy…Eurosets S.R.L20114—
+4K082117Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…Maquet Cardiopulmonary, AG2009215
+4K082412Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT…Mapquet Cardiopulmonary AG20080—
+5K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.20260—
+5K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—
+5K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)Chalice Medical, Ltd.20230—
+5K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L202212
+5K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L202121
+5K141492Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)Eurosets S.R.L20153—
+5K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG201341
+5K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+5K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+5K102532HLS Cannula Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG20111—
+5K101153Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod…Maquet Cardiopulmonary, AG201064
+5K090690Venous Softbag Reservoirs with Softline CoatingMaquet Cardiopulmonary, AG20090—
+5K090534Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG20092—
+5K090555Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Maquet Cardiopulmonary, AG200911
+5K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG20093—
+5K090518Quart Arterial Filter with Softline CoatingMaquet Cardiopulmonary, AG20090—
+5K090515Rotaflow Centrifugal Pump with Softline Coating, Model BO-RF-32 (Usa)Maquet Cardiopulmonary, AG200901
+5K090511Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Maquet Cardiopulmonary, AG2009123
+6K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.20250—
+6K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)…Qura S.R.L20230—
+6K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.202302
+6K202510AMG PMP InfantEurosets S.R.L20210—
+6K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG201522
+6K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+6K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+6K131666Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG201303
+6K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG201112
+6K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG200983
+7K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG20140Class I