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FDA 510(k)

Prelude IDeal Hydrophilic Sheath Introducer

K-Number: K173750 · 2018-02-15

ApplicantMerit Medical Systems, Inc.
Decision Date2018-02-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Prelude IDeal Hydrophilic Sheath Introducer is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-02-15 under approval number K173750. 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 IDeal Hydrophilic Sheath Introducer?

Prelude IDeal Hydrophilic Sheath Introducer is a medical device that received FDA 510(k) clearance on 2018-02-15. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K173750.

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

Prelude IDeal Hydrophilic Sheath Introducer received FDA 510(k) clearance on 2018-02-15, under approval number K173750.

What company makes Prelude IDeal Hydrophilic Sheath Introducer?

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

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

The FDA product code for Prelude IDeal 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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