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
DateFirm and productCodeLinked 510(k)
Apr 29, 2021Medtronic Perfusion Systems
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Terminated		 DWFK171979
Apr 24, 2020LivaNova USA Inc.
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
Terminated		 DWFK900753
Apr 24, 2020LivaNova USA Inc.
Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
Terminated		 DWFK900753
Nov 27, 2019Edwards Lifesciences, LLC
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Terminated		 DWFK981995
Nov 19, 2019Cardiac Assist, Inc
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s ven
Terminated		 DWFK162214
Oct 22, 2019Edwards Lifesciences, LLC
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174
Terminated		 DWFK123370
Jun 4, 2019OriGen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
Terminated		 DWFK113869
Jun 4, 2019OriGen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
Terminated		 DWFK113869
Jun 4, 2019OriGen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
Terminated		 DWFK113869
Jun 4, 2019OriGen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
Terminated		 DWFK113869
Jun 4, 2019OriGen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
Terminated		 DWFK113869
Jun 4, 2019OriGen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
Terminated		 DWFK113869
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 52301 Sash & Accessory Pack Material:-709000266R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal Material: 709000069R02
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3) Material: 701067370R03 BO-TOP 38803 OPEN HEART PACK W
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01
Terminated		 DWFK080592
May 31, 2019Maquet Cardiovascular, LLC
Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01
Terminated		 DWFK080592

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