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FDA 510(k)

ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR

K-Number: K083835 · 2009-01-23

ApplicantSt Jude Medical
Decision Date2009-01-23
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2009-01-23 under 510(k) number K083835. 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 ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR?

ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR is a medical device that received FDA 510(k) clearance on 2009-01-23. The listed applicant is St Jude Medical. The 510(k) number is K083835.

When did ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR receive FDA 510(k) clearance?

ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR received FDA 510(k) clearance on 2009-01-23, under 510(k) number K083835.

Who is the listed applicant for ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR?

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

What is the FDA product code for ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR?

The FDA product code for ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR 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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