ClearanceBrief
Panels › Cardiovascular › Product code DWF · Class 2

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Regulation 870.4210

8510(k)s in 12 months (403 all time)
20recalls in 12 months (563 all time)
544recalls that name a 510(k)
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Top companies in DWF

Company510(k)sRecalls
Maquet Cardiovascular0184
Terumo Cardiovascular Systems Corp.10143
Medtronic Perfusion Systems1277
Sorin Group USA, Inc.047
Edwards Lifesciences1921
Medtronic, Inc.311
Dlp, Inc.220
3M Health Care, Sarns210
Shiley, Inc.210
Edwards Lifesciences Research Medical413
Decided510(k)Device and applicantCode
Jan 9, 2015K141465CARDIOGARD EMBOLI PROTECTION CANNULA
Cardiogard Medical, Ltd.
DWF
Jan 7, 2015K143107DLP Vein Graft Cannula
Medtronic, Inc.
DWF
Nov 19, 2014K140569ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
Maquet Cardiopulmonary, AG, DE
DWF
Nov 18, 2014K142673Bio-Medicus Adult Cannulae and Introducer
Medtronic, Inc.
DWF
Nov 12, 2014K142593AngioVac Cannula
AngioDynamics, Inc.
DWF
Aug 15, 2014K141951DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
Medtronic, Inc.
DWF
Aug 6, 2014K140999TANDEMHEART VENO-VENOUS CANNULA
Cardiacassist, Inc.
DWF
May 22, 2014K140192CARPENTIER BI-CAVAL FEMORAL CANNULA
Medtronic, Inc.
DWF
May 20, 2014K140165MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE
Medtronic, Inc.
DWF
Mar 5, 2014K140208FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
Edwards Lifesciences, LLC
DWF
Mar 5, 2014K133445ANGIOVAC CANNULA
Vortex Medical, Inc.
DWF
Feb 27, 2014K132811SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
Terumo Cardiovascular Systems Corporation
DWF
Feb 18, 2014K132451SARNS SOFT-FLOW AORTIC CANNULA
Terumo Cardiovascular Systems Corp.
DWF
Feb 12, 2014K13329315 FR. TANDEMHEART ARTERIAL CANNULA
Cardiacassist, Inc.
DWF
Feb 3, 2014K133151SARNS HIGH FLOW AORTIC ARCH CANNULA
Terumo Cardiovascular Systems Corp.
DWF
Jan 29, 2014K133236TANDEMHEART FEMORAL VENOUS CANNULA SET
Cardiacassist, Inc.
DWF
Oct 31, 2013K132995DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO
Medtronic, Inc.
DWF
Jul 10, 2013K131269DLP CORONARY OSTIAL PERFUSION CANNULAE
Medtronic, Inc.
DWF
Jul 5, 2013K131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
Maquet Cardiopulmonary, AG, DE
DWF
May 16, 2013K130639ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
Maquet Cardiopulmonary, AG, DE
DWF
Mar 27, 2013K123762DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF
Medtronic, Inc.
DWF
Mar 22, 2013K123303FEMORAL ACCESS VENOUS CANNULAE
Edwards Lifesciences, LLC
DWF
Mar 15, 2013K123298FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
Edwards Lifesciences, LLC
DWF
Mar 13, 2013K123370EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA
Edwards Lifesciences, LLC
DWF
Feb 22, 2013K123187RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA
Edwards Lifesciences, LLC
DWF
Oct 19, 2012K122913AFFINITY FUSION RECIRCULATION LINE MODEL RCL841
Medtronic, Inc.
DWF
Jul 26, 2012K113869ORIGEN REINFORCED DUAL LUMEN CATHETER
Origen Biomedical, Inc.
DWF
Jul 25, 2012K120988DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT
Medtronic, Inc.
DWF
Jun 29, 2012K113459ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING
Edwards Lifesciences, LLC
DWF
Jun 27, 2012K120780EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
Edwards Lifesciences, LLC
DWF
Jun 11, 2012K113411EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA
Edwards Lifesciences, LLC
DWF
Jun 6, 2012K120987DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF
Medtronic, Inc.
DWF
May 30, 2012K120543TANDEMHEART FEMORAL ARTERIAL CANNULA SET
Cardiacassist, Inc.
DWF
May 25, 2012K120612MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
Medtronic, Inc.
DWF
May 8, 2012K120072VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
Edwards Lifesciences, LLC
DWF
Dec 6, 2011K112565NOVAPORT ONE VASCULAR ACCESS CANNULA
Novalung GmbH
DWF
Jul 19, 2011K111147MEDLINE VESSEL CANNULA
Medline Industries, Inc.
DWF
Jun 20, 2011K110983CENTRIMAG DRAINAGE CANNULA KIT
Levitronix, LLC
DWF
Jun 20, 2011K110980CENTRIMAG RETURN CANNULA KIT
Levitronix, LLC
DWF
Feb 25, 2011K102532HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
Maquet Cardiopulmonary, AG, DE
DWF
Oct 26, 2010K102420EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
Edwards Lifesciences, LLC
DWF
May 10, 2010K100274MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L
Medtronic, Inc.
DWF
Jan 14, 2010K093730PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
Edwards Lifesciences, LLC
DWF
Dec 18, 2009K090533HLM TUBING SET WITH SOFTLINE COATING
Maquet Cardiopulmonary, AG, DE
DWF
Oct 20, 2009K091542ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
Endoscopic Technologies, Inc. D/B/A Estech
DWF
Oct 8, 2009K092509EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
Edwards Lifesciences, LLC
DWF
Aug 27, 2009K090869MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD
Medtronic Perfusion Systems
DWF
Jul 2, 2009K091304VORTEX CANNULA
Vortex Medical, Inc.
DWF
Apr 3, 2009K090878MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)
Terumo Cardiovascular Systems Corp.
DWF
Feb 10, 2009K081560VASCUTEK CANNULA GRAFT, MODEL CGS2008S
Vascutek, Ltd., GB
DWF

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