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FDA 510(k)

Fountain ValveTip Infusion Catheter

K-Number: K193082 · 2020-08-07

Decision Date2020-08-07
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fountain ValveTip Infusion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-08-07 under 510(k) 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. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K193082.

When did Fountain ValveTip Infusion Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Fountain ValveTip Infusion Catheter?

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

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

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.

Other records listing Merit Medical Systems, Inc. as applicant

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.

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Related Devices (Code: KRA)

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.

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.