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FDA 510(k)

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY

K-Number: K792441 · 1980-03-17

ApplicantEdwards Laboratories
Decision Date1980-03-17
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking & PMS

Device Summary

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Laboratories. It received FDA 510(k) clearance on 1980-03-17 under 510(k) number K792441. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking & PMS.

Frequently Asked Questions

What is the CARPENTIER-EDWARDS FLEX. ANNULOPLASTY?

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY is a medical device that received FDA 510(k) clearance on 1980-03-17. The listed applicant is Edwards Laboratories. The 510(k) number is K792441.

When did CARPENTIER-EDWARDS FLEX. ANNULOPLASTY receive FDA 510(k) clearance?

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY received FDA 510(k) clearance on 1980-03-17, under 510(k) number K792441.

Who is the listed applicant for CARPENTIER-EDWARDS FLEX. ANNULOPLASTY?

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

What is the FDA product code for CARPENTIER-EDWARDS FLEX. ANNULOPLASTY?

The FDA product code for CARPENTIER-EDWARDS FLEX. ANNULOPLASTY is KRH.

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Other records listing Edwards Laboratories 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.

K801552MOD. 9542 FLOW-THRU INJECT. TEMP. SENSORK800655MODEL 100 SPECTRAVIEWK792034INTEGRAL DISPOSABLE HOLDER CARPENTIERK790047CARDIAC OUTPUT COMPUTER, MDEL 9520AK790022DISPOSABLE HOLDER FOR BIOPROSTHESISK781535AC ADAPTER:MODELS 9525,9526,9527

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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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