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Sources: EU EUDAMED, US FDA
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Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·December 18, 2013
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
FDA Enforcement
Class II
·Ongoing·Maquet Cardiovascular, LLC·July 3, 2024
Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 701053906R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD Material: 701051935R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-T-22800 Material: 701049506
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019