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FDA 510(k)

MERIT PRELUDE SHEATH INTRODUCER

K-Number: K050962 · 2005-05-06

ApplicantMerit Medical Systems, Inc.
Decision Date2005-05-06
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MERIT PRELUDE SHEATH INTRODUCER 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 2005-05-06 under 510(k) number K050962. 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 MERIT PRELUDE SHEATH INTRODUCER?

MERIT PRELUDE SHEATH INTRODUCER is a medical device that received FDA 510(k) clearance on 2005-05-06. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K050962.

When did MERIT PRELUDE SHEATH INTRODUCER receive FDA 510(k) clearance?

MERIT PRELUDE SHEATH INTRODUCER received FDA 510(k) clearance on 2005-05-06, under 510(k) number K050962.

Who is the listed applicant for MERIT PRELUDE SHEATH INTRODUCER?

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 MERIT PRELUDE SHEATH INTRODUCER?

The FDA product code for MERIT PRELUDE SHEATH INTRODUCER 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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