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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 occluding, temporary
510(k) Number K210602
Device Name AortaSTAT Occlusion Device
Applicant
RenalPro Medical, Inc.
2370-B Walsh Avenue
santa clara,  CA  95051
Applicant Contact james twitchell
Correspondent
Northwest Clinical Research Group, Inc.
19836 NE 125th Place
woodinville,  WA  98077
Correspondent Contact roberta hines
Regulation Number870.4450
Classification Product Code
MJN  
Date Received03/01/2021
Decision Date 07/09/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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