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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 K173661
Device Name Wingman 35 Crossing Catheter
Applicant
Reflow Medical, Inc.
1003 Calle Sombra
San Clemente,  CA  92673
Applicant Contact Rebecca K Pine
Correspondent
Reflow Medical, Inc.
1003 Calle Sombra
San Clemente,  CA  92673
Correspondent Contact Rebecca K Pine
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/29/2017
Decision Date 04/18/2018
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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