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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 K193596
Device Name Wingman 14, Wingman 14C, Wingman 18, Wingman 35
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  
Subsequent Product Code
PDU  
Date Received12/23/2019
Decision Date 02/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT03403426
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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