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FDA 510(k)

NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000

K-Number: K033685 · 2004-08-03

ApplicantMedical Cv, Inc.
Decision Date2004-08-03
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Cv, Inc.. It received FDA 510(k) clearance on 2004-08-03 under 510(k) number K033685. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000?

NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 is a medical device that received FDA 510(k) clearance on 2004-08-03. The listed applicant is Medical Cv, Inc.. The 510(k) number is K033685.

When did NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 receive FDA 510(k) clearance?

NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 received FDA 510(k) clearance on 2004-08-03, under 510(k) number K033685.

Who is the listed applicant for NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000?

The FDA 510(k) record lists Medical Cv, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000?

The FDA product code for NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 is KRH.

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Other records listing Medical Cv, Inc. as applicant

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Related Devices (Code: KRH)

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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