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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 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 2024-12-10 under 510(k) 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. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K241521.

When did Prelude Small O.D. Introducer Guide Wire receive FDA 510(k) clearance?

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

Who is the listed applicant for Prelude Small O.D. Introducer 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 Prelude Small O.D. Introducer Guide Wire?

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

Related Clinical Trials

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Other records listing Merit Medical Systems, Inc. as applicant

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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.

K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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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