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See today's BioWorld MedTech
Home » Cook prods FDA on balloon fatigue testing in catheter 510(k) draft guidance
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Cook prods FDA on balloon fatigue testing in catheter 510(k) draft guidance

March 13, 2020
By Mark McCarty
Balloon catheters are in abundant use across the human vasculature. Thus, the January U.S. FDA draft guidance for angioplasty and specialty catheters captured a range of critical devices. However, Stephen Ferguson, of Bloomington, Ind.-based Cook Group Inc., cited several problems he saw with the draft, including that one of the specifications for balloon fatigue testing exceeds the level spelled out in an international standard adopted by the FDA.
BioWorld MedTech Regulatory Cardiovascular Drug coated balloon FDA

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