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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K223216
Device Name Symphony Thrombectomy System
Applicant
Truvic Medical, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Applicant Contact Vida Sollanek
Correspondent
Cardiomed Devices Consultants
1783 Forest Dr.
Suite 254
Annappolis,  MD  21401
Correspondent Contact Semih Oktay
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received10/17/2022
Decision Date 02/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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