FDA Product Code
FDA Product Code DWF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4210
510(k) Clearances — 403 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K263092 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026-10-01 | Special | PDF ↗ |
| K262052 | Tri Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026-09-28 | Traditional | PDF ↗ |
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | Medtronic, Inc. | 2026-04-23 | Special | PDF ↗ |
| K250937 | Venous Return Cannulae | LivaNova USA, Inc. | 2026-03-11 | Traditional | PDF ↗ |
| K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) | Smart Reactors | 2026-02-23 | Traditional | PDF ↗ |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | Medtronic, Inc. | 2026-02-19 | Traditional | PDF ↗ |
| K253671 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026-01-30 | Traditional | PDF ↗ |
| K253998 | Clearview Intracoronary Shunts | Medtronic, Inc. | 2026-01-20 | Special | PDF ↗ |
| K253106 | AngioVac Cannula | AngioDynamics, Inc. | 2025-10-24 | Special | PDF ↗ |
| K250283 | RAP Femoral Venous Cannulae | LivaNova USA, Inc. | 2025-07-10 | Special | PDF ↗ |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. | 2025-06-27 | Special | PDF ↗ |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | Medtronic, Inc. | 2025-06-20 | Traditional | PDF ↗ |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | Spectrum Medical S.R.L. | 2024-05-31 | Special | PDF ↗ |
| K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) | Sorin Group Italia S.R.L. | 2024-02-22 | Special | PDF ↗ |
| K233895 | 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); | Edwards Lifesciences | 2024-02-05 | Special | PDF ↗ |
| K231206 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2023-12-07 | Special | PDF ↗ |
| K230960 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2023-05-04 | Special | PDF ↗ |
| K221353 | 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 | Qura S.R.L | 2022-08-18 | Special | PDF ↗ |
| K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | Qura S.R.L | 2022-05-20 | Traditional | PDF ↗ |
| K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F | Qura S.R.L | 2021-11-08 | Traditional | PDF ↗ |
| K212386 | AngioVac F18 85 | AngioDynamics, Inc. | 2021-09-30 | Traditional | PDF ↗ |
| K201100 | Bio-Medicus Life Support Catheter and Introducer | Medtronic, Inc. | 2021-07-15 | Traditional | PDF ↗ |
| K203057 | Quantum Perfusion Arterial Cannula Graft | Qura S.R.L | 2021-06-30 | Traditional | PDF ↗ |
| K200289 | Michler-Kapp Cardiovascular Vent Catheter | Kapp Surgical Instrument, Inc. | 2021-01-28 | Traditional | PDF ↗ |
| K200612 | R501 aortic root cannula without vent line, R502 aortic root cannula with vent line | Sorin Group Italia S.R.L. | 2020-11-17 | Traditional | PDF ↗ |
| K200499 | QuickDraw Venous Cannula | Edwards Lifesciences, LLC | 2020-03-29 | Special | PDF ↗ |
| K200358 | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula | Edwards Lifesciences, LLC | 2020-03-13 | Special | PDF ↗ |
| K190594 | AngioVac C20, AngioVac C180 | AngioDynamics, Inc. | 2019-07-05 | Traditional | PDF ↗ |
| K182302 | CardioGard Emboli Protection Cannula | Cardiogard Medical, Ltd. | 2019-05-17 | Traditional | PDF ↗ |
| K190557 | Bio-Medicus Insertion Kit | Medtronic, Inc. | 2019-04-03 | Special | PDF ↗ |
| K180979 | PureFlex Arterial Cannulae | Sorin Group Italia S.R.L. | 2018-11-16 | Traditional | PDF ↗ |
| K182586 | DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port | Medtronic, Inc. | 2018-10-19 | Special | PDF ↗ |
| K181150 | ProtekDuo Mini Veno-Venous Cannula Set | Cardiacassist, Inc. | 2018-05-25 | Special | PDF ↗ |
| K180456 | Bio-Medicus Adult Cannulae Kit | Medtronic, Inc. | 2018-03-22 | Special | PDF ↗ |
| K180453 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2018-03-22 | Special | PDF ↗ |
| K171979 | Tubing Pack | Medtronic, Inc. | 2017-10-27 | Special | PDF ↗ |
| K170488 | Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr | Surge Cardiovascular | 2017-08-10 | Traditional | PDF ↗ |
| K162215 | Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae | Sorin Group Italia S.R.L. | 2017-06-16 | Traditional | PDF ↗ |
| K171308 | Tubing Pack | Medtronic, Inc. | 2017-06-02 | Special | PDF ↗ |
| K162500 | Ostial Sprit Cannulae | Spyder Medical | 2017-01-12 | Traditional | PDF ↗ |
| K162214 | Protek Solo 24 Fr Venous Cannula Set | Cardiacassist, Inc. | 2016-11-30 | Traditional | PDF ↗ |
| K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set | Cardiacassist, Inc. | 2016-03-04 | Special | PDF ↗ |
| K153598 | Medtronic Bio-Medicus Adult Cannula Kit | Medtronic, Inc. | 2016-01-15 | Special | PDF ↗ |
| K152161 | Thoratec CentriMag Return (Arterial) Cannula Kit | Thoratec Corporation | 2015-09-18 | Special | PDF ↗ |
| K152190 | Thoratec CentriMag Drainage (Venous) Cannula Kit | Thoratec Corporation | 2015-09-18 | Special | PDF ↗ |
| K151523 | Uncoated Tubing and Connector Components | Medtronic, Inc. | 2015-07-16 | Special | PDF ↗ |
| K150536 | Terumo Circuit Tubing | Terumo Cardiovascular Systems Corporation | 2015-05-05 | Special | PDF ↗ |
| K150567 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT | Medtronic, Inc. | 2015-04-09 | Special | PDF ↗ |
| K143083 | Bio-Medicus Pediatric Cannula and Introducers | Medtronic, Inc. | 2015-03-25 | Traditional | PDF ↗ |
| K150422 | EOPA 3D Arterial Cannula | Medtronic, Inc. | 2015-03-20 | Special | PDF ↗ |
| K141465 | CARDIOGARD EMBOLI PROTECTION CANNULA | Cardiogard Medical, Ltd. | 2015-01-09 | Traditional | PDF ↗ |
| K143107 | DLP Vein Graft Cannula | Medtronic, Inc. | 2015-01-07 | Special | PDF ↗ |
| K140569 | ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) | Maquet Cardiopulmonary, AG | 2014-11-19 | Traditional | PDF ↗ |
| K142673 | Bio-Medicus Adult Cannulae and Introducer | Medtronic, Inc. | 2014-11-18 | Traditional | PDF ↗ |
| K142593 | AngioVac Cannula | AngioDynamics, Inc. | 2014-11-12 | Traditional | PDF ↗ |
| K141951 | DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE | Medtronic, Inc. | 2014-08-15 | Special | PDF ↗ |
| K140999 | TANDEMHEART VENO-VENOUS CANNULA | Cardiacassist, Inc. | 2014-08-06 | Traditional | PDF ↗ |
| K140192 | CARPENTIER BI-CAVAL FEMORAL CANNULA | Medtronic, Inc. | 2014-05-22 | Traditional | PDF ↗ |
| K140165 | MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE | Medtronic, Inc. | 2014-05-20 | Traditional | PDF ↗ |
| K140208 | FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII | Edwards Lifesciences, LLC | 2014-03-05 | Special | PDF ↗ |
| K133445 | ANGIOVAC CANNULA | Vortex Medical, Inc. | 2014-03-05 | Traditional | PDF ↗ |
| K132811 | SARNS SOFT-FLOW EXTENDED AORTIC CANNULA | Terumo Cardiovascular Systems Corporation | 2014-02-27 | Traditional | PDF ↗ |
| K132451 | SARNS SOFT-FLOW AORTIC CANNULA | Terumo Cardiovascular Systems Corp. | 2014-02-18 | Traditional | PDF ↗ |
| K133293 | 15 FR. TANDEMHEART ARTERIAL CANNULA | Cardiacassist, Inc. | 2014-02-12 | Special | PDF ↗ |
| K133151 | SARNS HIGH FLOW AORTIC ARCH CANNULA | Terumo Cardiovascular Systems Corp. | 2014-02-03 | Traditional | PDF ↗ |
| K133236 | TANDEMHEART FEMORAL VENOUS CANNULA SET | Cardiacassist, Inc. | 2014-01-29 | Traditional | PDF ↗ |
| K132995 | DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO | Medtronic, Inc. | 2013-10-31 | Special | PDF ↗ |
| K131269 | DLP CORONARY OSTIAL PERFUSION CANNULAE | Medtronic, Inc. | 2013-07-10 | Special | PDF ↗ |
| K131666 | ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | 2013-07-05 | Special | PDF ↗ |
| K130639 | ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER | Maquet Cardiopulmonary, AG | 2013-05-16 | Special | PDF ↗ |
| K123762 | DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF | Medtronic, Inc. | 2013-03-27 | Traditional | PDF ↗ |
| K123303 | FEMORAL ACCESS VENOUS CANNULAE | Edwards Lifesciences, LLC | 2013-03-22 | Traditional | PDF ↗ |
| K123298 | FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING | Edwards Lifesciences, LLC | 2013-03-15 | Traditional | PDF ↗ |
| K123370 | EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA | Edwards Lifesciences, LLC | 2013-03-13 | Traditional | PDF ↗ |
| K123187 | RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA | Edwards Lifesciences, LLC | 2013-02-22 | Traditional | PDF ↗ |
| K122913 | AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 | Medtronic, Inc. | 2012-10-19 | Traditional | PDF ↗ |
| K113869 | ORIGEN REINFORCED DUAL LUMEN CATHETER | Origen Biomedical, Inc. | 2012-07-26 | Traditional | PDF ↗ |
| K120988 | DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT | Medtronic, Inc. | 2012-07-25 | Special | PDF ↗ |
| K113459 | ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING | Edwards Lifesciences, LLC | 2012-06-29 | Traditional | PDF ↗ |
| K120780 | EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE | Edwards Lifesciences, LLC | 2012-06-27 | Traditional | PDF ↗ |
| K113411 | EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA | Edwards Lifesciences, LLC | 2012-06-11 | Traditional | PDF ↗ |
| K120987 | DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF | Medtronic, Inc. | 2012-06-06 | Special | PDF ↗ |
| K120543 | TANDEMHEART FEMORAL ARTERIAL CANNULA SET | Cardiacassist, Inc. | 2012-05-30 | Traditional | PDF ↗ |
| K120612 | MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT | Medtronic, Inc. | 2012-05-25 | Special | PDF ↗ |
| K120072 | VENOUS DRAINAGE CANNULA WITH DURAFLO COATING | Edwards Lifesciences, LLC | 2012-05-08 | Traditional | PDF ↗ |
| K112565 | NOVAPORT ONE VASCULAR ACCESS CANNULA | Novalung GmbH | 2011-12-06 | Traditional | PDF ↗ |
| K111147 | MEDLINE VESSEL CANNULA | Medline Industries, Inc. | 2011-07-19 | Traditional | PDF ↗ |
| K110983 | CENTRIMAG DRAINAGE CANNULA KIT | Levitronix, LLC | 2011-06-20 | Traditional | PDF ↗ |
| K110980 | CENTRIMAG RETURN CANNULA KIT | Levitronix, LLC | 2011-06-20 | Traditional | PDF ↗ |
| K102532 | HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | 2011-02-25 | Traditional | PDF ↗ |
| K102420 | EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA | Edwards Lifesciences, LLC | 2010-10-26 | Special | PDF ↗ |
| K100274 | MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L | Medtronic, Inc. | 2010-05-10 | Traditional | PDF ↗ |
| K093730 | PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) | Edwards Lifesciences, LLC | 2010-01-14 | Special | PDF ↗ |
| K090533 | HLM TUBING SET WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | 2009-12-18 | Special | PDF ↗ |
| K091542 | ESTECH EASYFLOW CANNULA WITH GUIDEWIRE | Endoscopic Technologies, Inc. D/B/A Estech | 2009-10-20 | Traditional | PDF ↗ |
| K092509 | EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE | Edwards Lifesciences, LLC | 2009-10-08 | Traditional | PDF ↗ |
| K090869 | MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD | Medtronic Perfusion Systems | 2009-08-27 | Traditional | PDF ↗ |
| K091304 | VORTEX CANNULA | Vortex Medical, Inc. | 2009-07-02 | Traditional | PDF ↗ |
| K090878 | MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) | Terumo Cardiovascular Systems Corp. | 2009-04-03 | Special | PDF ↗ |
| K081560 | VASCUTEK CANNULA GRAFT, MODEL CGS2008S | Vascutek, Ltd. | 2009-02-10 | Traditional | PDF ↗ |
Product code DWF · Class II · Cardiovascular. Data: openFDA.