Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- BYSOxygenator, Long Term Support Greater Than 6 Hours2Product Code
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2Product Code
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass2Product Code
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line2Product Code
- DTNReservoir, Blood, Cardiopulmonary Bypass2Product Code
- DTPDefoamer, Cardiopulmonary Bypass2Product Code
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass2Product Code
- DTRHeat-Exchanger, Cardiopulmonary Bypass2Product Code
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass2Product Code
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass2Product Code
- DTXGas Control Unit, Cardiopulmonary Bypass2Product Code
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass2Product Code
- DTZOxygenator, Cardiopulmonary Bypass2Product Code
- DWAControl, Pump Speed, Cardiopulmonary Bypass2Product Code
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type2Product Code
- DWCController, Temperature, Cardiopulmonary Bypass2Product Code
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass2Product Code
- DWETubing, Pump, Cardiopulmonary Bypass2Product Code
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2Product Code
- K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)2Cleared 510(K)
- K240193R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)2Cleared 510(K)
- K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);2Cleared 510(K)
- K231206DLP Silicone Coronary Artery Ostial Cannulae2Cleared 510(K)
- K230960DLP™ Silicone Coronary Artery Ostial Cannulae2Cleared 510(K)
- K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS2Cleared 510(K)
- K213540Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set2Cleared 510(K)
- K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F2Cleared 510(K)
- K212386AngioVac F18 852Cleared 510(K)
- K201100Bio-Medicus Life Support Catheter and Introducer2Cleared 510(K)
- K203057Quantum Perfusion Arterial Cannula Graft2Cleared 510(K)
- K200289Michler-Kapp Cardiovascular Vent Catheter2Cleared 510(K)
- K200612R501 aortic root cannula without vent line, R502 aortic root cannula with vent line2Cleared 510(K)
- K200499QuickDraw Venous Cannula2Cleared 510(K)
- K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula2Cleared 510(K)
- K190594AngioVac C20, AngioVac C1802Cleared 510(K)
- K182302CardioGard Emboli Protection Cannula2Cleared 510(K)
- K190557Bio-Medicus Insertion Kit2Cleared 510(K)
- K180979PureFlex Arterial Cannulae2Cleared 510(K)
- K182586DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port2Cleared 510(K)
- K181150ProtekDuo Mini Veno-Venous Cannula Set2Cleared 510(K)
- K180453Bio-Medicus Adult Cannulae and Introducer2Cleared 510(K)
- K180456Bio-Medicus Adult Cannulae Kit2Cleared 510(K)
- K171979Tubing Pack2Cleared 510(K)
- K170488Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr2Cleared 510(K)
- K162215Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae2Cleared 510(K)
- K171308Tubing Pack2Cleared 510(K)
- K162500Ostial Sprit Cannulae2Cleared 510(K)
- K162214Protek Solo 24 Fr Venous Cannula Set2Cleared 510(K)
- K160257PROTEK Duo 31 Fr. Veno-Venous Cannula Set2Cleared 510(K)
- K153598Medtronic Bio-Medicus Adult Cannula Kit2Cleared 510(K)
- K152190Thoratec CentriMag Drainage (Venous) Cannula Kit2Cleared 510(K)
- K152161Thoratec CentriMag Return (Arterial) Cannula Kit2Cleared 510(K)
- K151523Uncoated Tubing and Connector Components2Cleared 510(K)
- K150536Terumo Circuit Tubing2Cleared 510(K)
- K150567MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT2Cleared 510(K)
- K143083Bio-Medicus Pediatric Cannula and Introducers2Cleared 510(K)
- K150422EOPA 3D Arterial Cannula2Cleared 510(K)
- K141465CARDIOGARD EMBOLI PROTECTION CANNULA2Cleared 510(K)
- K143107DLP Vein Graft Cannula2Cleared 510(K)
- K140569ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)2Cleared 510(K)
- K142673Bio-Medicus Adult Cannulae and Introducer2Cleared 510(K)
- K142593AngioVac Cannula2Cleared 510(K)
- K141951DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE2Cleared 510(K)
- K140999TANDEMHEART VENO-VENOUS CANNULA2Cleared 510(K)
- K140192CARPENTIER BI-CAVAL FEMORAL CANNULA2Cleared 510(K)
- K140165MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE2Cleared 510(K)
- K140208FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII2Cleared 510(K)
- K133445ANGIOVAC CANNULA2Cleared 510(K)
- K132811SARNS SOFT-FLOW EXTENDED AORTIC CANNULA2Cleared 510(K)
- K132451SARNS SOFT-FLOW AORTIC CANNULA2Cleared 510(K)
- K13329315 FR. TANDEMHEART ARTERIAL CANNULA2Cleared 510(K)
- K133151SARNS HIGH FLOW AORTIC ARCH CANNULA2Cleared 510(K)
- K133236TANDEMHEART FEMORAL VENOUS CANNULA SET2Cleared 510(K)
- K132995DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO2Cleared 510(K)
- K131269DLP CORONARY OSTIAL PERFUSION CANNULAE2Cleared 510(K)
- K131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING2Cleared 510(K)
- K130639ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER2Cleared 510(K)
- K123762DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF2Cleared 510(K)
- K123303FEMORAL ACCESS VENOUS CANNULAE2Cleared 510(K)
- K123298FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING2Cleared 510(K)
- K123370EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA2Cleared 510(K)
- K123187RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA2Cleared 510(K)
- K122913AFFINITY FUSION RECIRCULATION LINE MODEL RCL8412Cleared 510(K)
- K113869ORIGEN REINFORCED DUAL LUMEN CATHETER2Cleared 510(K)
- K120988DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT2Cleared 510(K)
- K113459ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING2Cleared 510(K)
- K120780EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE2Cleared 510(K)
- K113411EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA2Cleared 510(K)
- K120987DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF2Cleared 510(K)
- K120543TANDEMHEART FEMORAL ARTERIAL CANNULA SET2Cleared 510(K)
- K120612MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT2Cleared 510(K)
- K120072VENOUS DRAINAGE CANNULA WITH DURAFLO COATING2Cleared 510(K)
- K112565NOVAPORT ONE VASCULAR ACCESS CANNULA2Cleared 510(K)
- K111147MEDLINE VESSEL CANNULA2Cleared 510(K)
- K110980CENTRIMAG RETURN CANNULA KIT2Cleared 510(K)
- K110983CENTRIMAG DRAINAGE CANNULA KIT2Cleared 510(K)
- K102532HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING2Cleared 510(K)
- K102420EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA2Cleared 510(K)
- K100274MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L2Cleared 510(K)
- K093730PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)2Cleared 510(K)
- K090533HLM TUBING SET WITH SOFTLINE COATING2Cleared 510(K)
- K091542ESTECH EASYFLOW CANNULA WITH GUIDEWIRE2Cleared 510(K)
- K092509EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE2Cleared 510(K)
- K090869MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD2Cleared 510(K)
- K091304VORTEX CANNULA2Cleared 510(K)
- K090878MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)2Cleared 510(K)
- K081560VASCUTEK CANNULA GRAFT, MODEL CGS2008S2Cleared 510(K)
- K081881GISH TUBING AND CONNECTORS WITH HA COATING2Cleared 510(K)
- K083301X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS2Cleared 510(K)
- K082344STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)2Cleared 510(K)
- K081820AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR2Cleared 510(K)
- K081933AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR2Cleared 510(K)
- K082425TANDEMHEART TRANSSEPTAL CANNULA- EF 722Cleared 510(K)
- K080034THREE STAGE VENOUS RETURN CANNULA, MODEL 8164602Cleared 510(K)
- K072172JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE2Cleared 510(K)
- K063618TENDERFLOW PERIATRIC ARTERIAL CANNULA2Cleared 510(K)
- K062597TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA2Cleared 510(K)
- K061832JOSTRA HLM TUBING SETS WITH SAFELINE COATING2Cleared 510(K)
- K061254EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,7832222Cleared 510(K)
- K060101ESTECH AORTIC EASY FLOW CANNULA2Cleared 510(K)
- K052570TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-62212Cleared 510(K)
- K052081REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA2Cleared 510(K)
- K052524BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT2Cleared 510(K)
- K052372MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C2Cleared 510(K)
- K042984INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C2Cleared 510(K)
- K043179SELECT 3D ARTERIAL CANNULA2Cleared 510(K)
- K042156CARDEON COBRA CATHETER2Cleared 510(K)
- K041650MICRO PRIME2Cleared 510(K)
- K033463EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE2Cleared 510(K)
- K033464EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE2Cleared 510(K)
- K032977JMS BYPASS TUBE2Cleared 510(K)
- K040173PEDIATRIC AORTIC ROOT CANNULA2Cleared 510(K)
- K020983JOSTRA SUCKERS, MODEL JS2Cleared 510(K)
- K034058SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 300112Cleared 510(K)
- K033416SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE2Cleared 510(K)
- K033264MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES2Cleared 510(K)
- K032632REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH2Cleared 510(K)
- K032041DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)2Cleared 510(K)
- K031776MC2X MULTI-STAGE VENOUS CANNULA2Cleared 510(K)
- K031827ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX2Cleared 510(K)
- K031151TS3 TUBING SET2Cleared 510(K)
- K031518EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,2Cleared 510(K)
- K031037EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE2Cleared 510(K)
- K030231CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON2Cleared 510(K)
- K030696RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)2Cleared 510(K)
- K020784JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS2Cleared 510(K)
- K024069ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 771062Cleared 510(K)
- K022272MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)2Cleared 510(K)
- K024058MODIFICATION TO CARDEON AEGIS CATHETER2Cleared 510(K)
- K023880CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER2Cleared 510(K)
- K023251PEDIATRIC ARTERIAL CANNULA2Cleared 510(K)
- K023056CIRCUIT TUBINGS WITH X-COATING2Cleared 510(K)
- K023622STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-352Cleared 510(K)
- K022280STOCKERT CORONARY PERFUSION CANNULAE2Cleared 510(K)
- K022321STOCKERT V172-28 VENOUS FEMORAL CANNULA2Cleared 510(K)
- K022022JOSTRA VENT CATHETERS, MODELS LV & HKV2Cleared 510(K)
- K020693AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF001012Cleared 510(K)
- K022042MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)2Cleared 510(K)
- K0207683T VESSEL CANNULAS2Cleared 510(K)
- K022174MODIFICATION TO CARDEON AEGIS CATHETER2Cleared 510(K)
- K013593CARDEON AEGIS CATHETER2Cleared 510(K)
- K020515JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA2Cleared 510(K)
- K002578AXILLARY ACCESS ARTERIAL CANNULA2Cleared 510(K)
- K014303JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE2Cleared 510(K)
- K013944JOSTRA DUAL STAGE VENOUS RETURN CANNULAE2Cleared 510(K)
- K013013MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.2Cleared 510(K)
- K012774JOSTRA ARTERIAL PERFUSION CANNULAE2Cleared 510(K)
- K012617JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...2Cleared 510(K)
- K001509STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE2Cleared 510(K)
- K012538TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE2Cleared 510(K)
- K010974RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET2Cleared 510(K)
- K010737SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,789242Cleared 510(K)
- K002019RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET2Cleared 510(K)
- K000776MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP2Cleared 510(K)
- K002273STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE2Cleared 510(K)
- K001961STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE2Cleared 510(K)
- K003371PUMP TUBING WITH X-COATING2Cleared 510(K)
- K002857ELS CANNULA (KIT), MODEL M1210-88,M1510-882Cleared 510(K)
- K002366QUEST MPS BACK-UP SYSYEM2Cleared 510(K)
- K000830CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE2Cleared 510(K)
- K001565STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB2Cleared 510(K)
- K001371CARDEON ASCENDING BALLOON CANNULA (ABC)2Cleared 510(K)
- K994209STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP2Cleared 510(K)
- K992932CIPA (ADULTS) CIPI (INFANTS)2Cleared 510(K)
- K994243DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP2Cleared 510(K)
- K994171MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE2Cleared 510(K)
- K993677MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT2Cleared 510(K)
- K000274EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE2Cleared 510(K)
- K993818ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE2Cleared 510(K)
- K991541A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-442Cleared 510(K)
- K990396T-ANASTAFLO2Cleared 510(K)
- K991066MADTRONIC DLP ARTERIAL CANNULAE2Cleared 510(K)
- K983270VOYAGER QUAD CANNULA2Cleared 510(K)
- K991170RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-0142Cleared 510(K)
- K983791PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA2Cleared 510(K)
- K981995QUICKDRAW VENOUS CANNULA2Cleared 510(K)
- K990772DIRECTFLOW ARTERIAL CANNULA2Cleared 510(K)
- K974259VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE2Cleared 510(K)
- K981009HEARTPORT ENDOPULMONARY VENT CATHETER2Cleared 510(K)
- K981601CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER2Cleared 510(K)
- K974736HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER2Cleared 510(K)
- K964205BETTER-TUBING2Cleared 510(K)
- K972993CHASE FEMORAL ACCESS CANNULATION SET2Cleared 510(K)
- K971928QUEST VESSEL CATHETER2Cleared 510(K)
- K972261RIVETTI-LEVINSON INSTRALUMINAL SHUNT2Cleared 510(K)
- K971023CHASE THORACIC CATHETER2Cleared 510(K)
- K972503CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE2Cleared 510(K)
- K972665CHASE BLOOD VESSEL SHUNT2Cleared 510(K)
- K971021CHASE PHRENIC NERVE PAD2Cleared 510(K)
- K971019CHASE VESSEL CANNULA2Cleared 510(K)
- K964373SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT2Cleared 510(K)
- K964374SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT2Cleared 510(K)
- K971291HEARTPORT ENDOARTERIAL RETURN CANNULA2Cleared 510(K)
- K971041CHASE CORONARY OSTIAL PERFUSION CANNULA2Cleared 510(K)
- K970914CHASE AORTIC PERFUSION CANNULA2Cleared 510(K)
- K964391CHASE LEFT VENT SAFETY VALVE2Cleared 510(K)
- K964393CHASE RETROGRADE CARDIOPLEGIA CANNULA2Cleared 510(K)
- K964193CHASE AORTIC ARCH CANNULA2Cleared 510(K)
- K964194CHASE CURVED LEFT HEART VENT CATHETER2Cleared 510(K)
- K964200CHASE MULTIPLE PERFUSION SET2Cleared 510(K)
- K964198CAHSE AORTIC ROOT CANNULA2Cleared 510(K)
- K964195CHASE TWO STAGE VENOUS RETURN CATHETER2Cleared 510(K)
- K964199CHASE CORONARY SINUS PERFUSION CANNULA2Cleared 510(K)
- K962835HEARTPORT ENDOVENOUS DRAINAGE CANNULA2Cleared 510(K)
- K964248HEARTPORT ENDOCORONARY SINUS CATHETR2Cleared 510(K)
- K961594BETTER-VENTER2Cleared 510(K)
- K961927RMI HEMOCONCENTRACTOR TUBING SET2Cleared 510(K)
- K961717NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS2Cleared 510(K)
- K961180NMI ANTEGRAD CARDIOPLEGIA CANNULA2Cleared 510(K)
- K961270HEARTPORT ENDOSINUS CATHETER2Cleared 510(K)
- K961245HEARTPORT ENDOPULMONARY VENT2Cleared 510(K)
- K955121HEARTPORT ENDOARTERIAL RETURN CANNUAL2Cleared 510(K)
- K955818FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER2Cleared 510(K)
- K953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET2Cleared 510(K)
- K951088QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS2Cleared 510(K)
- K943934AORTIC ARCH CANNULAS2Cleared 510(K)
- K950814QUEST ANTEGRADE CARDIOPLEGIA CANNULA2Cleared 510(K)
- K941916QUEST CORONARY SINUS PERFUSION CANNULA -FRCC2Cleared 510(K)
- K941166QUEST CORONARY SINUS PERFUSION CANNULA2Cleared 510(K)
- K932208EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM2Cleared 510(K)
- K934127SARNS LOW JETTING AORTIC ARCH CANNULA2Cleared 510(K)
- K925049QUEST HEART INSULATION PAD2Cleared 510(K)
- K931586VITAL-PORT MINI VASCULAR ACCESS SYSTEM2Cleared 510(K)
- K924529SIGNATURE(TM) CUSTOM TUBING PACK2Cleared 510(K)
- K925442SARNS RETROGRADE CANNULA2Cleared 510(K)
- K930684BARD WILLIAM HARVEY TWO STAGE CANNULA2Cleared 510(K)
- K920902MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA2Cleared 510(K)
- K930620BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA2Cleared 510(K)
- K930593BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU2Cleared 510(K)
- K924642MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER2Cleared 510(K)
- K923483BARD WILLIAM HARVEY AORTIC ARCH CANULAE2Cleared 510(K)
- K922471SARNS RETROGRADE CANNULA - AUTO INFLATE2Cleared 510(K)
- K924643MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT2Cleared 510(K)
- K922992CONDUCER CARDIOPLEGIA SET SITH MP42Cleared 510(K)
- K915268CATHETER TWO STAGE VENOUS RETURN2Cleared 510(K)
- K915193SARNS RETROGRADE CANNULA2Cleared 510(K)
- K910004FURUI SHUNT, 2-WAY AND 3-WAY2Cleared 510(K)
- K910021CARDIOPULMONARY BYPASS PUMP TUBING2Cleared 510(K)
- K905224CARDIOPULMONARY BYPASS VASCULAR CATHETER2Cleared 510(K)
- K905638SARNS INVENT CATHETERS2Cleared 510(K)
- K905312DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS2Cleared 510(K)
- K902394RESUBMITTED MULTIORGAN PERFUSION CANNULA2Cleared 510(K)
- K902277BARD EXTRACORPOREAL CIRCULATION CANNULAE2Cleared 510(K)
- K901074CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA2Cleared 510(K)
- K901231RMI CARDIOPLEGIA DELIVERY KITS2Cleared 510(K)
- K896338VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA2Cleared 510(K)
- K900753SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)2Cleared 510(K)
- K897022PICSO CANNULA, CATALOG CODE 943152Cleared 510(K)
- K896777RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE2Cleared 510(K)
- K896778RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE2Cleared 510(K)
- K897026CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.2Cleared 510(K)
- K896636RMI ANTEPLEGIA CANNULA2Cleared 510(K)
- K895352KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN2Cleared 510(K)
- K894684PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT2Cleared 510(K)
- K891576FEM-FLEX FEMORAL ACCESS CANNULATION SET2Cleared 510(K)
- K890980MODIFIED STOCKERT-SHILEY VENOUS CATHETER2Cleared 510(K)
- K890024SARNS VENT CATHETER2Cleared 510(K)
- K883412THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)2Cleared 510(K)
- K885188MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY2Cleared 510(K)
- K884310ANGIOPUMP TUBING SET2Cleared 510(K)
- K884393MODIFIED SHILEY FEMORAL ARTERIAL CANNULA2Cleared 510(K)
- K883981GUIDING CATHETER (TIP SOFTNESS CHANGE)2Cleared 510(K)
- K883221PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT2Cleared 510(K)
- K882771EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER2Cleared 510(K)
- K882034INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER2Cleared 510(K)
- K881733SHILEY FEMORAL CORONARY PERFUSION CATHETER2Cleared 510(K)
- K881734SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER2Cleared 510(K)
- K881691PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA2Cleared 510(K)
- K881330COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK2Cleared 510(K)
- K881352RIGHT ATRIAL CATHETER INSERTION TRAY2Cleared 510(K)
- K881074SHILEY FEMORAL VENOUS CANNULA2Cleared 510(K)
- K881072SHILEY FEMORAL ARTERIAL CANNULA2Cleared 510(K)
- K880887NEOCATH2Cleared 510(K)
- K8807778.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM2Cleared 510(K)
- K880779MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY2Cleared 510(K)
- K880421DESCENDING ARCH CANNULA2Cleared 510(K)
- K880180STATFLO2Cleared 510(K)
- K880103CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL.2Cleared 510(K)
- K875353PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT2Cleared 510(K)
- K875048SARNS VENOATRIAL CATHETER2Cleared 510(K)
- K874899CANYON MEDICAL FEMORAL BYPASS CANNULAE2Cleared 510(K)
- K874852POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS2Cleared 510(K)
- K874853POLYSTAN TWO STAGE CATHETERS2Cleared 510(K)
- K874896SARNS VISIFLOW AORTIC ARCH CANNULA2Cleared 510(K)
- K874834ARGYLE CARDIOPLEGIA CANNULA2Cleared 510(K)
- K872033BIO-MEDICUS CANNULA-TUBING2Cleared 510(K)
- K873212SARNS CARDIOPLEGIA/VENT CATHETERS2Cleared 510(K)
- K872043CHURCHILL INTER-CARDIAC SUCKER2Cleared 510(K)
- K872788MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN2Cleared 510(K)
- K872762TORAY ANTHRON AORTA BYPASS TUBES2Cleared 510(K)
- K872159DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES2Cleared 510(K)
- K871844ARGYLE VASCULAR BYPASS SET2Cleared 510(K)
- K870819BUBBLE TRAP CAT. NO. B-1802Cleared 510(K)
- K870421TDMAC-HEPARIN COATED RMI2Cleared 510(K)
- K870507GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA2Cleared 510(K)
- K870109RMI VENOUS DRAINAGE CANNULA2Cleared 510(K)
- K865079ASPIRATING NEEDLE, CATALOG CODE #120062Cleared 510(K)
- K863342SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER2Cleared 510(K)
- K863740RMI FEMORAL VENOUS DRAINAGE CANNULA2Cleared 510(K)
- K863558URESIL CAROTID SHUNT2Cleared 510(K)
- K862190WALRUS: DOUBLE BALLOON SHUNTING CATHETER2Cleared 510(K)
- K862634TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT2Cleared 510(K)
- K861790RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT2Cleared 510(K)
- K860136BARD-PARKER CAROTID SHUNT2Cleared 510(K)
- K861310STOCKERT-SHILEY AORTIC ROOT CANNULAE2Cleared 510(K)
- K861322RMI POROUS VENT PLUG2Cleared 510(K)
- K861116TORAY ANTHRON BYPASS TUBES2Cleared 510(K)
- K861103CHEST DRAINAGE PACK, CDP-10002Cleared 510(K)
- K860743CAROTID BYPASS SHUNT WITH SAMPLING ARM2Cleared 510(K)
- K860742CAROTID BYPASS SHUNT2Cleared 510(K)
- K860497CAROTID BALLOON SHUNT2Cleared 510(K)
- K861496STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA2Cleared 510(K)
- K861096CARDIOPULMONARY CANNULA TUBING2Cleared 510(K)
- K860988RMI CAROTID BY-PASS SHUNT2Cleared 510(K)
- K860149VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 940152Cleared 510(K)
- K854640MODIFIED CORONARY CARDIOPLEGIA ADAPTOR2Cleared 510(K)
- K854487VENOUS RETURN CANNULA W/CUFF 910392Cleared 510(K)
- K853128SARNS EVACUPLEGE CATHETER2Cleared 510(K)
- K852984SHILEY CSD EXTENSION LINE WITH FILTER2Cleared 510(K)
- K851323AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU2Cleared 510(K)
- K833047DOSIMETRIC RELEASE OF RAD. TUBING PAC2Cleared 510(K)
- K850917ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN2Cleared 510(K)
- K850925BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER2Cleared 510(K)
- K850385INTRACARDIAC SUMP 120102Cleared 510(K)
- K845045VENOUS RETURN CATHETER SS-12Cleared 510(K)
- K845046PUL,MONARY ARTERY VENT CATHETER2Cleared 510(K)
- K850356PRUITT-VASCULAR SHUNTS2Cleared 510(K)
- K844137STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN2Cleared 510(K)
- K844138STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI2Cleared 510(K)
- K844139STOCKERT-SHILEY INTRACARDIAC SUCKERS2Cleared 510(K)
- K844140STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH2Cleared 510(K)
- K843542SHILEY CORONARY CARDIOPLEGIA ADAPTOR2Cleared 510(K)
- K843444ARGYLE SILICONE LEFT VENTRICULAR AND2Cleared 510(K)
- K842889ARGYLE CUSTOM TUBING PACK2Cleared 510(K)
- K842375VENOUS CANNULA W/BENT, TIP WIRE2Cleared 510(K)
- K841482PRESSURE CATHETER PLACEMENT SET 500102Cleared 510(K)
- K840914ARGYLE TAPERED VASCULAR SHUNT2Cleared 510(K)
- K834134SARNS 8.0 SOFT ARC CANNULA2Cleared 510(K)
- K8338303-DAY BIOINDICATOR RELEASE PROCESS FOR2Cleared 510(K)
- K840001ARTERIAL CANNULA STRAIGHT BEVELED TIP2Cleared 510(K)
- K840002ARTERIAL CANNULA CURVED BEVELED TIP2Cleared 510(K)
- K834039INFANT VENT CATHETER 12001 W/SIDE VENT2Cleared 510(K)
- K834025SARNS CARDIOPLEGIA CANNULA Y2Cleared 510(K)
- K833112TUBING FOR CARDIOPULMONARY BYPASS2Cleared 510(K)
- K832475AXIOM PERFUSSION CANNULA2Cleared 510(K)
- K832124CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI2Cleared 510(K)
- K831759INTRACARDIA SUCKERS2Cleared 510(K)
- K831769VARIOUS CARDIOVASCULAR SURGICAL DEVICE2Cleared 510(K)
- K831130DISPOS. ABODOMINAL RETRACTING PAD2Cleared 510(K)
- K831330UNIVERSAL CORONARY CANNULA2Cleared 510(K)
- K831591AORTIC ROOT CANNULA W/INTEGRAL PRESS2Cleared 510(K)
- K831332ARGYLE DUAL STAGE VENOUS RETURN CATH.2Cleared 510(K)
- K830728CARDIOVASCULAR DISPOSABLE PRODUCTS2Cleared 510(K)
- K822317ARGYLE CAROTID ARTERY LOOP SHUNT2Cleared 510(K)
- K822210SARNS CARDIOPLEGIA CANNULAE (VAR. TYPES2Cleared 510(K)
- K821316KONTRON LITWAK-KOFFSKY OBTURATED CANNU2Cleared 510(K)
- K821445ARGYLE FERGUSON LEFT ATRIAL VENT CATH2Cleared 510(K)
- K821149SUBMISSION CORONARY CANNULA2Cleared 510(K)
- K813037FLOWGUARD CATHETERS & CANNALAE2Cleared 510(K)
- K810515DISPOSABLE 2-STAGE CANNULA2Cleared 510(K)
- K810820CARDIOPULMONARY BYPASS2Cleared 510(K)
- K810548CARDIOPULMINARY BYPASS CATHETER CANNULA2Cleared 510(K)
- K810415SARNS TWO-STATE WIRE REINFORCED CATHETER2Cleared 510(K)
- K802543RIDGID VENA CAVA CANNULAE2Cleared 510(K)
- K802378QUICK PRIME LINES, #'S BPL-12, BPL-48 &2Cleared 510(K)
- K802261PRESSURE GAUGE ACCESSORY KIT/DILATATION2Cleared 510(K)
- K801770ARTERIAL BUBBLE TRAP2Cleared 510(K)
- K801359PRUITT VASCULAR SHUNT2Cleared 510(K)
- K801403DISPOSABLE PERFUSION SET2Cleared 510(K)
- K801401CARDIOPULMONARY BYPASS TUBING2Cleared 510(K)
- K801398AORTIC AND FEMORAL PERFUSION CANNULAE2Cleared 510(K)
- K801397VENA CAVA CANNULAE2Cleared 510(K)
- K801396SAPHENOUS VEIN CANNULAE2Cleared 510(K)
- K801392DISPOSABLE SUMP SETS2Cleared 510(K)
- K792070SARNS MEDIASTINAL AND PERICARDIAL TUBE2Cleared 510(K)
- K792202TROCAR CATHETER/THORACIC CATHETER2Cleared 510(K)
- K792152CARDIOPLEGIA SOLUTION ADMIN. SET2Cleared 510(K)
- K791947SHILEY CARDIOPLEGIC SOLUTION DEL SETS2Cleared 510(K)
- K791858CARDIOPLEGIA ADMIN. SETS2Cleared 510(K)
- K791972ARGYLE PEDIATRIC VENA CAVAL CATHETER2Cleared 510(K)
- K791832VEIN GRAFT CANNULA2Cleared 510(K)
- K790565AORTIC ROOT CANNULA2Cleared 510(K)
- K790246SARNS WIRE-REINFORCED VENOUS RETURN CAN2Cleared 510(K)
- K781990CARDIAC INSULATION PAD2Cleared 510(K)
- K771692TUBING SETS2Cleared 510(K)
- K771499FLEXIBLE ARTERIAL CANNULAE2Cleared 510(K)
- K770431CATHETER, TWO STAGE VENOUS RETURN2Cleared 510(K)
- K770430CATHETER, CURVED LEFT HEART VENT2Cleared 510(K)
- K770429CANNULAE, AORTIC, ARCH, HIGH FLOW2Cleared 510(K)
- K770068CANNULA, HUNTER-SESSIONS, SELF-RETAIN.2Cleared 510(K)
- DWPDilator, Vessel, Surgical2Product Code
- DWQStripper, Vein, External2Product Code
- DWSInstruments, Surgical, Cardiovascular1Product Code
- DWXStripper, Artery, Intraluminal2Product Code
- DWZDevice, Biopsy, Endomyocardial2Product Code
- DXCClamp, Vascular2Product Code
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass2Product Code
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass2Product Code
- JORGenerator, Pulsatile Flow, Cardiopulmonary Bypass3Product Code
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type2Product Code
- KRIAccessory Equipment, Cardiopulmonary Bypass1Product Code
- KRJFilter, Prebypass, Cardiopulmonary Bypass2Product Code
- KRLDetector, Bubble, Cardiopulmonary Bypass2Product Code
- LXNProbe, Test, Heart-Valve1Product Code
- MCWCatheter, Peripheral, Atherectomy2Product Code
- MFYEndothelial Cell Harvesting Kit2Product Code
- MGZValvulotome2Product Code
- MJJCpb Check Valve, Retrograde Flow, In-Line2Product Code
- MJNCatheter, Intravascular Occluding, Temporary2Product Code
- MNJValve, Pressure Relief, Cardiopulmonary Bypass2Product Code
- MWSStabilizer, Heart1Product Code
- NCPCannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection2Product Code
- NLJStripper, Vein, External, Reprocessed2Product Code
- NMFClamp, Vascular, Reprocessed2Product Code
- NQGStabilizer, Heart, Non-Compression, Reprocessed1Product Code
- OETCardioplegia Solution Administration Kit2Product Code
- OEUCardiopulmonary Bypass Catheter Kit2Product Code
- OFACardiovascular Surgical Instruments Tray1Product Code
- OFGCt Biopsy Tray2Product Code
- PNQApical Closure Device2Product Code
- PYXTemporary Non-Roller Type Right Heart Support Blood Pump3Product Code
- PTNReservoir, Blood, Cardiopulmonary Bypass, Exempt2Product Code
- PZSDual Lumen Ecmo Cannula2Product Code
- QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure2Product Code
- QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use2Product Code
- QOHExtracorporeal System For Carbon Dioxide Removal2Product Code
- QHWSingle Lumen Ecmo Cannula2Product Code
- QTFReprocessed Atherectomy Catheter2Product Code
- QWFTubing, Long Term Support Greater Than 6 Hours2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K123298
- 510(k) Type
- Traditional
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/15/2013
- Days to Decision
- 143 days
- Submission Type
- Summary