FDA-Device2019-03-06Class II
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.
BrosMed Medical Co.,Ltd.
Hazard
Incorrect (higher) Rated Burst Pressure information printed on label.
Sold states
US Distribution to MO.
Affected count
400
Manufactured in
Bubugaogaofu Lou Lou 15th, Songshan Lake Hi, Dongguan, China
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0963-2019Don't want to check this manually?
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