Atlas FDA

DWF

401 FDA 510(k) clearances · Product code

83 daysmedian time to decision
231 days90th percentile
401clearances measured

FDA profile

Official device name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4210
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 162 · 2022: 276 · 2023: 470 · 2024: 401 · 2025: 1,031 · 2026: 731
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195)Medtronic, Inc.2026-04-23
Venous Return Cannulae (K250937)LivaNova USA, Inc.2026-03-11
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) (K260043)Smart Reactors2026-02-23
Retrograde Coronary Sinus Perfusion Cannulae (K253203)Medtronic, Inc.2026-02-19
Dual Stage Venous Cannulae (K253671)Sorin Group Italia S.R.L.2026-01-30
Clearview Intracoronary Shunts (K253998)Medtronic, Inc.2026-01-20
AngioVac Cannula (K253106)AngioDynamics, Inc.2025-10-24
RAP Femoral Venous Cannulae (K250283)LivaNova USA, Inc.2025-07-10
Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (K250610)Sorin Group Italia S.R.L.2025-06-27
MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (K251258)Medtronic, Inc.2025-06-20
Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (K241248)Spectrum Medical S.R.L.2024-05-31
R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) (K240193)Sorin Group Italia S.R.L.2024-02-22
EZ 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); (K233895)Edwards Lifesciences2024-02-05
DLP Silicone Coronary Artery Ostial Cannulae (K231206)Medtronic, Inc.2023-12-07
DLP™ Silicone Coronary Artery Ostial Cannulae (K230960)Medtronic, Inc.2023-05-04
Quantum 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-VS (K221353)Qura S.R.L2022-08-18
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set (K213540)Qura S.R.L2022-05-20
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F (K203067)Qura S.R.L2021-11-08
AngioVac F18 85 (K212386)AngioDynamics, Inc.2021-09-30
Bio-Medicus Life Support Catheter and Introducer (K201100)Medtronic, Inc.2021-07-15
Quantum Perfusion Arterial Cannula Graft (K203057)Qura S.R.L2021-06-30
Michler-Kapp Cardiovascular Vent Catheter (K200289)Kapp Surgical Instrument, Inc.2021-01-28
R501 aortic root cannula without vent line, R502 aortic root cannula with vent line (K200612)Sorin Group Italia S.R.L.2020-11-17
QuickDraw Venous Cannula (K200499)Edwards Lifesciences, LLC2020-03-29
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula (K200358)Edwards Lifesciences, LLC2020-03-13
AngioVac C20, AngioVac C180 (K190594)AngioDynamics, Inc.2019-07-05
CardioGard Emboli Protection Cannula (K182302)Cardiogard Medical, Ltd.2019-05-17
Bio-Medicus Insertion Kit (K190557)Medtronic, Inc.2019-04-03
PureFlex Arterial Cannulae (K180979)Sorin Group Italia S.R.L.2018-11-16
DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port (K182586)Medtronic, Inc.2018-10-19
ProtekDuo Mini Veno-Venous Cannula Set (K181150)Cardiacassist, Inc.2018-05-25
Bio-Medicus Adult Cannulae and Introducer (K180453)Medtronic, Inc.2018-03-22
Bio-Medicus Adult Cannulae Kit (K180456)Medtronic, Inc.2018-03-22
Tubing Pack (K171979)Medtronic, Inc.2017-10-27
Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr (K170488)Surge Cardiovascular2017-08-10
Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae (K162215)Sorin Group Italia S.R.L.2017-06-16
Tubing Pack (K171308)Medtronic, Inc.2017-06-02
Ostial Sprit Cannulae (K162500)Spyder Medical2017-01-12
Protek Solo 24 Fr Venous Cannula Set (K162214)Cardiacassist, Inc.2016-11-30
PROTEK Duo 31 Fr. Veno-Venous Cannula Set (K160257)Cardiacassist, Inc.2016-03-04
Medtronic Bio-Medicus Adult Cannula Kit (K153598)Medtronic, Inc.2016-01-15
Thoratec CentriMag Drainage (Venous) Cannula Kit (K152190)Thoratec Corporation2015-09-18
Thoratec CentriMag Return (Arterial) Cannula Kit (K152161)Thoratec Corporation2015-09-18
Uncoated Tubing and Connector Components (K151523)Medtronic, Inc.2015-07-16
Terumo Circuit Tubing (K150536)Terumo Cardiovascular Systems Corporation2015-05-05
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT (K150567)Medtronic, Inc.2015-04-09
Bio-Medicus Pediatric Cannula and Introducers (K143083)Medtronic, Inc.2015-03-25
EOPA 3D Arterial Cannula (K150422)Medtronic, Inc.2015-03-20
CARDIOGARD EMBOLI PROTECTION CANNULA (K141465)Cardiogard Medical, Ltd.2015-01-09
DLP Vein Graft Cannula (K143107)Medtronic, Inc.2015-01-07
ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) (K140569)Maquet Cardiopulmonary, AG2014-11-19
Bio-Medicus Adult Cannulae and Introducer (K142673)Medtronic, Inc.2014-11-18
AngioVac Cannula (K142593)AngioDynamics, Inc.2014-11-12
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE (K141951)Medtronic, Inc.2014-08-15
TANDEMHEART VENO-VENOUS CANNULA (K140999)Cardiacassist, Inc.2014-08-06
CARPENTIER BI-CAVAL FEMORAL CANNULA (K140192)Medtronic, Inc.2014-05-22
MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE (K140165)Medtronic, Inc.2014-05-20
ANGIOVAC CANNULA (K133445)Vortex Medical, Inc.2014-03-05
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII (K140208)Edwards Lifesciences, LLC2014-03-05
SARNS SOFT-FLOW EXTENDED AORTIC CANNULA (K132811)Terumo Cardiovascular Systems Corporation2014-02-27
SARNS SOFT-FLOW AORTIC CANNULA (K132451)Terumo Cardiovascular Systems Corp.2014-02-18
15 FR. TANDEMHEART ARTERIAL CANNULA (K133293)Cardiacassist, Inc.2014-02-12
SARNS HIGH FLOW AORTIC ARCH CANNULA (K133151)Terumo Cardiovascular Systems Corp.2014-02-03
TANDEMHEART FEMORAL VENOUS CANNULA SET (K133236)Cardiacassist, Inc.2014-01-29
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO (K132995)Medtronic, Inc.2013-10-31
DLP CORONARY OSTIAL PERFUSION CANNULAE (K131269)Medtronic, Inc.2013-07-10
ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING (K131666)Maquet Cardiopulmonary, AG2013-07-05
ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER (K130639)Maquet Cardiopulmonary, AG2013-05-16
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF (K123762)Medtronic, Inc.2013-03-27
FEMORAL ACCESS VENOUS CANNULAE (K123303)Edwards Lifesciences, LLC2013-03-22
FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING (K123298)Edwards Lifesciences, LLC2013-03-15
EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA (K123370)Edwards Lifesciences, LLC2013-03-13
RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA (K123187)Edwards Lifesciences, LLC2013-02-22
AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 (K122913)Medtronic, Inc.2012-10-19
ORIGEN REINFORCED DUAL LUMEN CATHETER (K113869)Origen Biomedical, Inc.2012-07-26
DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT (K120988)Medtronic, Inc.2012-07-25
ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING (K113459)Edwards Lifesciences, LLC2012-06-29
EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE (K120780)Edwards Lifesciences, LLC2012-06-27
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA (K113411)Edwards Lifesciences, LLC2012-06-11
DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF (K120987)Medtronic, Inc.2012-06-06
TANDEMHEART FEMORAL ARTERIAL CANNULA SET (K120543)Cardiacassist, Inc.2012-05-30
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT (K120612)Medtronic, Inc.2012-05-25
VENOUS DRAINAGE CANNULA WITH DURAFLO COATING (K120072)Edwards Lifesciences, LLC2012-05-08
NOVAPORT ONE VASCULAR ACCESS CANNULA (K112565)Novalung GmbH2011-12-06
MEDLINE VESSEL CANNULA (K111147)Medline Industries, Inc.2011-07-19
CENTRIMAG DRAINAGE CANNULA KIT (K110983)Levitronix, LLC2011-06-20
CENTRIMAG RETURN CANNULA KIT (K110980)Levitronix, LLC2011-06-20
HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING (K102532)Maquet Cardiopulmonary, AG2011-02-25
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA (K102420)Edwards Lifesciences, LLC2010-10-26
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L (K100274)Medtronic, Inc.2010-05-10
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) (K093730)Edwards Lifesciences, LLC2010-01-14
HLM TUBING SET WITH SOFTLINE COATING (K090533)Maquet Cardiopulmonary, AG2009-12-18
ESTECH EASYFLOW CANNULA WITH GUIDEWIRE (K091542)Endoscopic Technologies, Inc. D/B/A Estech2009-10-20
EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE (K092509)Edwards Lifesciences, LLC2009-10-08
MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD (K090869)Medtronic Perfusion Systems2009-08-27
VORTEX CANNULA (K091304)Vortex Medical, Inc.2009-07-02
MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) (K090878)Terumo Cardiovascular Systems Corp.2009-04-03
VASCUTEK CANNULA GRAFT, MODEL CGS2008S (K081560)Vascutek, Ltd.2009-02-10
GISH TUBING AND CONNECTORS WITH HA COATING (K081881)Gish Biomedical, Inc.2009-01-23
X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS (K083301)Terumo Cardiovascular Systems Corp.2008-12-18
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