Merit RadialFlo Arterial Catheter

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Merit Medical Singapore Pte. Ltd.

The following data is part of a premarket notification filed by Merit Medical Singapore Pte. Ltd. with the FDA for Merit Radialflo Arterial Catheter.

Pre-market Notification Details

Device IDK182538
510k NumberK182538
Device Name:Merit RadialFlo Arterial Catheter
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant Merit Medical Singapore Pte. Ltd. 198 Yishun Avenue 7 Singapore,  SG 768926
ContactXing Ting Seow
CorrespondentXing Ting Seow
Merit Medical Singapore Pte. Ltd. 198 Yishun Avenue 7 Singapore,  SG 768926
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-14
Decision Date2019-01-16
Summary:summary

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