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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K243549
Device Name JETi Hydrodynamic Thrombectomy System
Applicant
Abbott Medical
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Applicant Contact Fiona Pu
Correspondent
Abbott Medical
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Correspondent Contact Fiona Pu
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Codes
FOX   KDQ  
Date Received11/15/2024
Decision Date 04/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04370691
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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