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FDA 510(k)

PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS

K-Number: K073035 · 2007-11-20

ApplicantMerit Medical Systems, Inc.
Decision Date2007-11-20
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS 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 2007-11-20 under 510(k) number K073035. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS?

PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS is a medical device that received FDA 510(k) clearance on 2007-11-20. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K073035.

When did PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS receive FDA 510(k) clearance?

PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS received FDA 510(k) clearance on 2007-11-20, under 510(k) number K073035.

Who is the listed applicant for PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS?

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 AND PRELUDE PRO SHEATH INTRODUCERS?

The FDA product code for PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS is DRE.

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Related Devices (Code: DRE)

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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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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