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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
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