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FDA 510(k)

CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS

K-Number: K914972 · 1992-01-09

ApplicantBaxter Healthcare Corp
Decision Date1992-01-09
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1992-01-09 under 510(k) number K914972. 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 CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS?

CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS is a medical device that received FDA 510(k) clearance on 1992-01-09. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K914972.

When did CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS receive FDA 510(k) clearance?

CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS received FDA 510(k) clearance on 1992-01-09, under 510(k) number K914972.

Who is the listed applicant for CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS?

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

What is the FDA product code for CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS?

The FDA product code for CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS 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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