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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 the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Singapore Pte. , Ltd.. It received FDA 510(k) clearance on 2019-01-16 under 510(k) 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. The listed applicant is Merit Medical Singapore Pte. , Ltd.. The 510(k) number is K182538.

When did Merit RadialFlo Arterial Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Merit RadialFlo Arterial Catheter?

The FDA 510(k) record lists Merit Medical Singapore Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: FOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited

Official Source

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

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