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FDA 510(k)

Merit RadialFlo Arterial Catheter

K-Number: K182538 · 2019-01-16

ApplicantMerit Medical Singapore Pte. , Ltd.
Decision Date2019-01-16
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Merit RadialFlo Arterial Catheter is a medical device manufactured by Merit Medical Singapore Pte. , Ltd.. It received FDA 510(k) clearance on 2019-01-16 under approval number K182538. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Merit RadialFlo Arterial Catheter?

Merit RadialFlo Arterial Catheter is a medical device that received FDA 510(k) clearance on 2019-01-16. It is manufactured by Merit Medical Singapore Pte. , Ltd.. The 510(k) number is K182538.

When was Merit RadialFlo Arterial Catheter approved by the FDA?

Merit RadialFlo Arterial Catheter received FDA 510(k) clearance on 2019-01-16, under approval number K182538.

What company makes Merit RadialFlo Arterial Catheter?

Merit RadialFlo Arterial Catheter is manufactured by Merit Medical Singapore Pte. , Ltd..

What is the FDA product code for Merit RadialFlo Arterial Catheter?

The FDA product code for Merit RadialFlo Arterial Catheter is FOZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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