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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 K200094
Device Name speX LP Support Catheter
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 Received01/16/2020
Decision Date 03/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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