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FDA 510(k)

Prelude Wave Hydrophilic Sheath Introducer

K-Number: K250909 · 2025-04-25

ApplicantMerit Medical Systems, Inc.
Decision Date2025-04-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Prelude Wave Hydrophilic Sheath Introducer is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-04-25 under approval number K250909. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prelude Wave Hydrophilic Sheath Introducer?

Prelude Wave Hydrophilic Sheath Introducer is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K250909.

When was Prelude Wave Hydrophilic Sheath Introducer approved by the FDA?

Prelude Wave Hydrophilic Sheath Introducer received FDA 510(k) clearance on 2025-04-25, under approval number K250909.

What company makes Prelude Wave Hydrophilic Sheath Introducer?

Prelude Wave Hydrophilic Sheath Introducer is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for Prelude Wave Hydrophilic Sheath Introducer?

The FDA product code for Prelude Wave Hydrophilic Sheath Introducer is DYB.

Related Clinical Trials

NCT07218406 Comparison of Merit Prelude Ideal and Terumo Glidesheath Slender Radial Artery Sheaths COMPLETED

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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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