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FDA 510(k)

Merit Hydrophilic Guide Wire

K-Number: K201595 · 2020-10-14

Decision Date2020-10-14
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Merit Hydrophilic Guide Wire 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 2020-10-14 under 510(k) number K201595. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Merit Hydrophilic Guide Wire?

Merit Hydrophilic Guide Wire is a medical device that received FDA 510(k) clearance on 2020-10-14. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K201595.

When did Merit Hydrophilic Guide Wire receive FDA 510(k) clearance?

Merit Hydrophilic Guide Wire received FDA 510(k) clearance on 2020-10-14, under 510(k) number K201595.

Who is the listed applicant for Merit Hydrophilic Guide Wire?

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 Merit Hydrophilic Guide Wire?

The FDA product code for Merit Hydrophilic Guide Wire is DQX.

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: DQX)

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.