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FDA 510(k)

Prelude Small O.D. Introducer Guide Wire

K-Number: K241521 · 2024-12-10

ApplicantMerit Medical Systems, Inc.
Decision Date2024-12-10
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Prelude Small O.D. Introducer Guide Wire is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-12-10 under approval number K241521. 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 Prelude Small O.D. Introducer Guide Wire?

Prelude Small O.D. Introducer Guide Wire is a medical device that received FDA 510(k) clearance on 2024-12-10. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K241521.

When was Prelude Small O.D. Introducer Guide Wire approved by the FDA?

Prelude Small O.D. Introducer Guide Wire received FDA 510(k) clearance on 2024-12-10, under approval number K241521.

What company makes Prelude Small O.D. Introducer Guide Wire?

Prelude Small O.D. Introducer Guide Wire is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for Prelude Small O.D. Introducer Guide Wire?

The FDA product code for Prelude Small O.D. Introducer Guide Wire is DQX.

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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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