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https://manuals.sjm.com/~/media/manuals/product-manual-pdfs/f/c/fcba81dd-ae2f-46fb-9306-40d1418d6240.pdf
delivery system by AMPLATZER™ device size, or refer to Table 3 to select the delivery system with a sheath that has the correct inner diameter as indicated in the device’s instructions for use. 2. Prepare the delivery system for use: - Inspect the sterile pouch and verify that it is unopened and undamaged. Do not use the components if 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.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://professional.sjm.com/~/media/pro/resources/ifu/amplatzer-us/sh-ds/600274-002_TorqVue_45_x_45_eIFU_amplatzer_torqvue_45x45_us.ashx
CAUTION: When placing a device using an AMPLATZER Torq Vue Delivery Sheath, refer to the instructions for use provided with the device. General instructions for the AMPLATZER TorqVue Delivery Sheaths are provided below: 1. Select the appropriate AMPLATZER TorqVue Delivery Sheath for the device that will be introduced through the sheath. 2.
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1380405
The amplatzer torque delivery system (sheath and dilator) was received at aga medical. Visual inspection determined the distal half of the sheath did not have a …
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://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://centennialheart.com/patient-center/patient-education/amplatzer.dot
The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. The two discs are linked together by a short, connecting waist, allowing free motion of each disc. ... Pass the delivery cable through the loader and screw the device on to the delivery cable.Location: 2400 Patterson St Suite 502, Nashville, 37203, TN
https://www.medicaldevices24.com/medical_devices/info/amplatzer-torqvue-45x45-delivery-sheath/585635
Medical Device AMPLATZER TORQVUE 45X45 DELIVERY SHEATH - 9-TV45X45-09F-100 The medical device AMPLATZER TORQVUE 45X45 DELIVERY SHEATH is realized by AGA MEDICAL CORPORATION Trade name
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