2 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
FDA Enforcement
Class I
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·March 25, 2015
Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
FDA Recall
Terminated
·Medtronic Inc. Cardiac Rhythm Disease Management·Product code DYB·February 23, 2015