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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K243948
Device Name Raptor Aspiration Catheter; Balt Aspiration Tubing Set
Applicant
Balt USA, LLC
29, Parker
Irvine,  CA  92618
Applicant Contact Catherine Chiou
Correspondent
Balt USA, LLC
29, Parker
Irvine,  CA  92618
Correspondent Contact Catherine Chiou
Regulation Number870.1250
Classification Product Code
NRY  
Date Received12/23/2024
Decision Date 06/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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