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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 K180904
Device Name Sniper Infusion Catheter with Balloon Occlusion
Applicant
Embolx, Inc.
530 Lakeside, Suite 200
Sunnyvale,  CA  94085
Applicant Contact Greg Haistead
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number870.4450
Classification Product Code
MJN  
Date Received04/06/2018
Decision Date 06/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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