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FDA 510(k)

ANNULOFLO SYSTEM, MITRAL MODEL AR700

K-Number: K021051 · 2002-04-23

ApplicantSulzer Carbomedics, Inc.
Decision Date2002-04-23
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANNULOFLO SYSTEM, MITRAL MODEL AR700 is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Carbomedics, Inc.. It received FDA 510(k) clearance on 2002-04-23 under 510(k) number K021051. 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 ANNULOFLO SYSTEM, MITRAL MODEL AR700?

ANNULOFLO SYSTEM, MITRAL MODEL AR700 is a medical device that received FDA 510(k) clearance on 2002-04-23. The listed applicant is Sulzer Carbomedics, Inc.. The 510(k) number is K021051.

When did ANNULOFLO SYSTEM, MITRAL MODEL AR700 receive FDA 510(k) clearance?

ANNULOFLO SYSTEM, MITRAL MODEL AR700 received FDA 510(k) clearance on 2002-04-23, under 510(k) number K021051.

Who is the listed applicant for ANNULOFLO SYSTEM, MITRAL MODEL AR700?

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

What is the FDA product code for ANNULOFLO SYSTEM, MITRAL MODEL AR700?

The FDA product code for ANNULOFLO SYSTEM, MITRAL MODEL AR700 is KRH.

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Other records listing Sulzer Carbomedics, Inc. as applicant

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Related Devices (Code: KRH)

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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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