2 results
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43ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·BrosMed Medical Co.,Ltd.·March 6, 2019
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
FDA Recall
Terminated
·BrosMed Medical Co., Ltd. Bubugaogaofu Lou Lou 15th Songshan Lake Hi Dongguan China·Product code LIT·December 14, 2018