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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K182538
Device Name Merit RadialFlo Arterial Catheter
Applicant
Merit Medical Singapore Pte. Ltd.
198 Yishun Avenue 7
Singapore,  SG 768926
Applicant Contact Xing Ting Seow
Correspondent
Merit Medical Singapore Pte. Ltd.
198 Yishun Avenue 7
Singapore,  SG 768926
Correspondent Contact Xing Ting Seow
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/14/2018
Decision Date 01/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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