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FDA 510(k)

Prelude IDeal 9F Hydrophilic Sheath Introducer

K-Number: K212152 · 2022-01-07

Decision Date2022-01-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Prelude IDeal 9F Hydrophilic Sheath Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K212152. 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 9F Hydrophilic Sheath Introducer?

Prelude IDeal 9F Hydrophilic Sheath Introducer is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Merit Medical Systems. The 510(k) number is K212152.

When did Prelude IDeal 9F Hydrophilic Sheath Introducer receive FDA 510(k) clearance?

Prelude IDeal 9F Hydrophilic Sheath Introducer received FDA 510(k) clearance on 2022-01-07, under 510(k) number K212152.

Who is the listed applicant for Prelude IDeal 9F Hydrophilic Sheath Introducer?

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

What is the FDA product code for Prelude IDeal 9F Hydrophilic Sheath Introducer?

The FDA product code for Prelude IDeal 9F Hydrophilic Sheath Introducer is DYB.

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 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: DYB)

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.