2 results
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14ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
FDA Enforcement
Class III
·Terminated·Medtronic Vascular·October 3, 2018
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.
FDA Enforcement
Class III
·Terminated·Medtronic Vascular·March 5, 2014