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FDA 510(k)

MERIT MAK (MINI ACCESS KIT)

K-Number: K031691 · 2003-09-03

ApplicantMerit Medical Systems, Inc.
Decision Date2003-09-03
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MERIT MAK (MINI ACCESS KIT) 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 2003-09-03 under 510(k) number K031691. 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 MAK (MINI ACCESS KIT)?

MERIT MAK (MINI ACCESS KIT) is a medical device that received FDA 510(k) clearance on 2003-09-03. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K031691.

When did MERIT MAK (MINI ACCESS KIT) receive FDA 510(k) clearance?

MERIT MAK (MINI ACCESS KIT) received FDA 510(k) clearance on 2003-09-03, under 510(k) number K031691.

Who is the listed applicant for MERIT MAK (MINI ACCESS KIT)?

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 MAK (MINI ACCESS KIT)?

The FDA product code for MERIT MAK (MINI ACCESS KIT) is DRE.

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Other records listing Merit Medical Systems, Inc. as applicant

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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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