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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K212977
Device Name SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
Applicant
Cordis Corporation
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact Vidya Venkataraghavan
Correspondent
Cordis Corporation
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact Vidya Venkataraghavan
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/17/2021
Decision Date 02/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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