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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 K210188
Device Name coraCross
Applicant
Reflow Medical
208 Avenida Fabricante #100
San Clemente,  CA  92672
Applicant Contact Krystal Santiago
Correspondent
Reflow Medical
208 Avenida Fabricante #100
San Clemente,  CA  92672
Correspondent Contact Krystal Santiago
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/25/2021
Decision Date 05/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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