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

DateFirm and productCodeLinked 510(k)
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253
Terminated
DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228
Terminated
DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060
Terminated
DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994
Terminated
DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510
Terminated
DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T-22800 Material: 701049506
Terminated
DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346
Terminated
DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690
Terminated
DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539
Terminated
DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962
Terminated
DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087
Terminated
DWFK080592
Nov 9, 2018LivaNova USA
Perfusion Pack, Rx only, Sterile EO
Terminated
DWFK881330
Nov 7, 2018OriGen Biomedical, Inc.
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainag
Terminated
DWFK113869
Aug 21, 2018OriGen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Terminated
DWFK113869
Aug 21, 2018OriGen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion o
Terminated
DWFK113869
Aug 21, 2018OriGen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusi
Terminated
DWFK113869
Aug 21, 2018OriGen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of
Terminated
DWFK113869
Aug 21, 2018OriGen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion o
Terminated
DWFK113869
Aug 21, 2018OriGen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of
Terminated
DWFK113869
Aug 21, 2018OriGen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated
Terminated
DWFK113869
Jul 18, 2018Surge Medical Sales, LLC (DBA Surge Cardiovascular)
Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of
Terminated
DWFK964199
May 14, 2018Maquet Cardiopulmonary Ag
Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass
Terminated
DWFK012774
May 14, 2018Maquet Cardiopulmonary Ag
Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
Terminated
DWFK012774
May 14, 2018Maquet Cardiopulmonary Ag
Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
Terminated
DWFK012774
Mar 7, 2018SPS Sterilization, Inc
Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.
Terminated
DWFK140208
Mar 7, 2018SPS Sterilization, Inc
Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
Terminated
DWFK140208
Mar 7, 2018SPS Sterilization, Inc
Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
Terminated
DWFK120072
Mar 7, 2018SPS Sterilization, Inc
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
Terminated
DWFK120072
Mar 7, 2018SPS Sterilization, Inc
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
Terminated
DWFK120072
Mar 7, 2018SPS Sterilization, Inc
Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
Terminated
DWFK123370
Mar 7, 2018SPS Sterilization, Inc
Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
Terminated
DWFK123370
Jan 30, 2018Medtronic Perfusion Systems
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Terminated
DWFK171308
Oct 20, 2017OriGen Biomedical, Inc.
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat
Terminated
DWFK113869
Sep 28, 2017Sorin Group USA, Inc.
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective
Terminated
DWFK052081
Jul 10, 2017Medtronic Perfusion Systems
DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Terminated
DWFK831591
Jul 10, 2017Medtronic Perfusion Systems
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with t
Terminated
DWFK831591
Jun 9, 2017Sorin Group USA, Inc.
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary by
Terminated
DWFK943934
Sep 8, 2016Sorin Group USA, Inc.
Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl fe
Terminated
DWFK030231
K972503
Sep 8, 2016Sorin Group USA, Inc.
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypas
Terminated
DWFK943934
Jul 8, 2016Sorin Group USA, Inc.
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit durin
Terminated
DWFK943934
Feb 26, 2016Medtronic Perfusion Systems
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into
Terminated
DWFK012538
K891687 +1
Feb 16, 2016Sorin Group USA, Inc.
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Car
Terminated
DWFK943934
Jan 19, 2016Sorin Group USA, Inc.
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built
Terminated
DWFK881330
Dec 9, 2015Edwards Lifesciences, LLC
Thin-Flex Venous Cannula, Model Number:TF292902A
Terminated
DWFK120072
Oct 28, 2015Medtronic Perfusion Systems
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consi
Terminated
DWFK012538
Aug 19, 2015Medtronic Perfusion Systems
Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
Terminated
DWFK031037
Jun 26, 2015Medtronic Perfusion Systems
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator com
Terminated
DWFK875353
Apr 23, 2015OriGen Biomedical, Inc.
OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a sin
Terminated
DWFK113869
Apr 2, 2015Edwards Lifesciences, LLC
Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEM
Terminated
DWFK140208
Nov 14, 2014Edwards Lifesciences, LLC
Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left
Terminated
DWFK113411

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