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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K233350
Device Name SINC Support Catheter
Applicant
Reflow Medical, Inc.
208 Avenida Fabricante
#100
San Clemente,  CA  92672
Applicant Contact Lori Grace
Correspondent
Reflow Medical, Inc.
208 Avenida Fabricante
#100
San Clemente,  CA  92672
Correspondent Contact Lori Grace
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/29/2023
Decision Date 02/08/2024
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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