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FDA 510(k)

MONARCH AP(TM)

K-Number: K943597 · 1995-02-10

ApplicantMerit Medical Systems, Inc.
Decision Date1995-02-10
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONARCH AP(TM) 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 1995-02-10 under 510(k) number K943597. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONARCH AP(TM)?

MONARCH AP(TM) is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K943597.

When did MONARCH AP(TM) receive FDA 510(k) clearance?

MONARCH AP(TM) received FDA 510(k) clearance on 1995-02-10, under 510(k) number K943597.

Who is the listed applicant for MONARCH AP(TM)?

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 MONARCH AP(TM)?

The FDA product code for MONARCH AP(TM) is MAV.

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Related Devices (Code: MAV)

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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