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FDA 510(k)

ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800

K-Number: K023185 · 2002-12-17

ApplicantSulzer Carbomedics, Inc.
Decision Date2002-12-17
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 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 2002-12-17 under 510(k) number K023185. 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 ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800?

ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 is a medical device that received FDA 510(k) clearance on 2002-12-17. The listed applicant is Sulzer Carbomedics, Inc.. The 510(k) number is K023185.

When did ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 receive FDA 510(k) clearance?

ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 received FDA 510(k) clearance on 2002-12-17, under 510(k) number K023185.

Who is the listed applicant for ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800?

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 ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800?

The FDA product code for ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 is KRH.

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Other records listing Sulzer Carbomedics, Inc. as applicant

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.

K013022SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESISK021051ANNULOFLO SYSTEM, MITRAL MODEL AR700K002007SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESISK993288SULZER CARBOMEDICS CARDIOFIX PERICARDIUMK992056ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800K974648SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR

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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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