FDA-Device2015-08-26Class II
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
Cordis Corporation
Hazard
Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or withdrawal of the catheter.
Sold states
Distributed in Germany only.
Affected count
98 units
Manufactured in
14201 Nw 60th Ave, Miami Lakes, FL, United States
Products
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2405-2015Don't want to check this manually?
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