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510(k) Data Aggregation
K Number
K182538Device Name
Merit RadialFlo Arterial Catheter
Manufacturer
Date Cleared
2019-01-16
(124 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Merit Medical Singapore Pte. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Merit RadialFlo Arterial Catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood and monitor blood pressure. The Merit RadialFlo Arterial Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Device Description
The Merit RadialFlo Arterial Catheter is an intravascular catheter designed to access the vasculature to sample blood and monitor blood pressure. The device is equipped with a Floswitch to limit blood spill or control flow as needed. The needle includes a unique notch to provide instant blood return upon vessel entry. The radiopaque catheter provides visibility under X-ray and fluoroscopy.
The arterial catheter is intended to be in contact with the circulating blood for a prolonged (24 hours to 30 days) duration. The steel needle is in contact with circulating blood for a limited (<24 hours) duration and the flow control plug has indirect blood path contact. All the materials used in Merit RadialFlo Arterial Catheter are biocompatible.
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