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FDA 510(k)

SEGUIN ANNULOPLASTY RING

K-Number: K092310 · 2009-08-27

ApplicantSt Jude Medical
Decision Date2009-08-27
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SEGUIN ANNULOPLASTY RING 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 2009-08-27 under 510(k) number K092310. 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 SEGUIN ANNULOPLASTY RING?

SEGUIN ANNULOPLASTY RING is a medical device that received FDA 510(k) clearance on 2009-08-27. The listed applicant is St Jude Medical. The 510(k) number is K092310.

When did SEGUIN ANNULOPLASTY RING receive FDA 510(k) clearance?

SEGUIN ANNULOPLASTY RING received FDA 510(k) clearance on 2009-08-27, under 510(k) number K092310.

Who is the listed applicant for SEGUIN ANNULOPLASTY RING?

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 SEGUIN ANNULOPLASTY RING?

The FDA product code for SEGUIN ANNULOPLASTY RING 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.

K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l.K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l.K253232Seguin Annuloplasty RingABBOTT MEDICALK251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLCK251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLCK250859TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.

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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