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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K201100
Device Name Bio-Medicus Life Support Catheter and Introducer
Applicant
Medtronic Inc.
8200 Coral Sea St. NE
Mounds Views,  MN  55112
Applicant Contact Juli Rubin
Correspondent
Medtronic Inc.
8200 Coral Sea St. NE
Mounds Views,  MN  55112
Correspondent Contact Juli Rubin
Regulation Number870.4210
Classification Product Code
DWF  
Date Received04/24/2020
Decision Date 07/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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