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FDA 510(k)

MICARDIA ANNULOPLASTY BAND DR

K-Number: K070488 · 2008-09-04

ApplicantMicardia Corporation
Decision Date2008-09-04
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MICARDIA ANNULOPLASTY BAND DR is the device name listed in this FDA 510(k) record. The listed applicant is Micardia Corporation. It received FDA 510(k) clearance on 2008-09-04 under 510(k) number K070488. 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 MICARDIA ANNULOPLASTY BAND DR?

MICARDIA ANNULOPLASTY BAND DR is a medical device that received FDA 510(k) clearance on 2008-09-04. The listed applicant is Micardia Corporation. The 510(k) number is K070488.

When did MICARDIA ANNULOPLASTY BAND DR receive FDA 510(k) clearance?

MICARDIA ANNULOPLASTY BAND DR received FDA 510(k) clearance on 2008-09-04, under 510(k) number K070488.

Who is the listed applicant for MICARDIA ANNULOPLASTY BAND DR?

The FDA 510(k) record lists Micardia Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICARDIA ANNULOPLASTY BAND DR?

The FDA product code for MICARDIA ANNULOPLASTY BAND DR is KRH.

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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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