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FDA 510(k)

Fountain ValveTip Infusion Catheter

K-Number: K193082 · 2020-08-07

ApplicantMerit Medical Systems, Inc.
Decision Date2020-08-07
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fountain ValveTip Infusion Catheter is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-08-07 under approval number K193082. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fountain ValveTip Infusion Catheter?

Fountain ValveTip Infusion Catheter is a medical device that received FDA 510(k) clearance on 2020-08-07. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K193082.

When was Fountain ValveTip Infusion Catheter approved by the FDA?

Fountain ValveTip Infusion Catheter received FDA 510(k) clearance on 2020-08-07, under approval number K193082.

What company makes Fountain ValveTip Infusion Catheter?

Fountain ValveTip Infusion Catheter is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for Fountain ValveTip Infusion Catheter?

The FDA product code for Fountain ValveTip Infusion Catheter is KRA.

Related Clinical Trials

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Related Devices (Code: KRA)

K161962VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC K160884CXI Support CatheterCook Incorporated K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. K161801CrossCath Support CatheterCook Incorporated K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.

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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