We have collected information about Amplatzer Torqvue Delivery System for you. Follow the links to find out details on Amplatzer Torqvue Delivery System.
https://manuals.sjm.com/~/media/manuals/product-manual-pdfs/f/c/fcba81dd-ae2f-46fb-9306-40d1418d6240.pdf
The AMPLATZER™ TorqVue™ delivery system is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Contraindications None known. Warnings • The sheath is designed to be used with the loader. Do not attach a syringe directly to the sheath ...
https://manuals.sjm.com/~/media/manuals/product-manual-pdfs/e/8/e8f4a87e-3156-4e4f-a7f7-56374bcb6822.pdf
3 Procedure CAUTION: When placing a device using an AMPLATZER™ TorqVue™ LP Delivery System, refer to the instructions for use provided with the device. General instructions for the AMPLATZER™ TorqVue™ LP Delivery System are provided below. 1. Select the appropriate delivery system for the device you be will using.
https://www.cardiovascular.abbott/us/en/hcp/products/structural-heart/amplatzer-pfo.html
Amplatzer PFO Occluder is the industry’s leading patent foramen ovale (PFO) closure device with over 100,000 devices implanted worldwide. See clinical data.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=115439
The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions. FDA Determined Cause 2: Device Design: Action: St. Jude Medical sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated January 18, 2013 to all affected customers.
https://professional.sjm.com/~/media/pro/resources/ifu/amplatzer-us/sh-pda/600207-008_PDA_eIFU_clean_amplatzer_duct_occluder_us.ashx
The AMPLATZER 180° Delivery System is composed of a delivery sheath, dilator, loader, plastic vise, and delivery cable. 180° indicates the curve of the delivery sheath. Indications and Usage The AMPLATZER Duct Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).
http://professional.sjm.com/~/media/pro/resources/ifu/amplatzer-us/sh-ds/600266-002_TorqVue_Del_Syst_secure_amplatzer_torqvue_45and180_delivery_system_us.ashx
Materials recommended for use with the delivery system Exchange-length 0.035-inch guidewire Procedure CAUTION: Refer to the instructions for use provided with the device when placing an AMPLATZER device using an AMPLATZER TorqVue Delivery System. General instructions for the AMPLATZER TorqVue Delivery Systems are provided below. 1.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=88348
AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the …
https://www.structuralheartsolutions.com/us/index.php?id=131&L=0
AMPLATZER TM DUCT OCCLUDER AND DELIVERY SYSTEM INDICATIONS AND USAGE. The AMPLATZER TM Duct Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).. CONTRAINDICATIONS. Patients weighing less than 6 kg; Patients less than 6 months of age; Presence of thrombus at the intended site of implant, or …
https://www.dicardiology.com/content/st-jude-medical-recalls-amplatzer-torqvue-fx-delivery-system
St. Jude Medical has issued a Class I recall for its Amplatzer TorqVue FX Delivery System used in transcatheter closure of atrial septal defects (ASDs). The company said in a small number of cases, the distal end of the core wire of the TorqVue FX system can fracture, which has the potential to cause serious adverse health consequences, including death.
https://www.esutures.com/product/1-expired/107-st.-jude-medical/1018-amplatzer/46248387-sjm-amplatzer-torqvue-delivery-system-12f--45--80cm-9-ITV12F4580/
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