Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Physio Flex Annuloplasty Ring

K-Number: K192762 · 2019-12-16

ApplicantEdwards Lifesciences, LLC
Decision Date2019-12-16
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Physio Flex Annuloplasty Ring is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2019-12-16 under 510(k) number K192762. 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 Physio Flex Annuloplasty Ring?

Physio Flex Annuloplasty Ring is a medical device that received FDA 510(k) clearance on 2019-12-16. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K192762.

When did Physio Flex Annuloplasty Ring receive FDA 510(k) clearance?

Physio Flex Annuloplasty Ring received FDA 510(k) clearance on 2019-12-16, under 510(k) number K192762.

Who is the listed applicant for Physio Flex Annuloplasty Ring?

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

What is the FDA product code for Physio Flex Annuloplasty Ring?

The FDA product code for Physio Flex Annuloplasty Ring is KRH.

Related Clinical Trials

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.

NCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITINGNCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITINGNCT03745313Edwards CLASP TR EFSCOMPLETEDNCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITINGNCT04375332Beating Heart Mitral Valve Repair With the HARPOON™ SystemACTIVE_NOT_RECRUITING

Other records listing Edwards Lifesciences, LLC 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.

PMA P230013Percutaneously Delivered Prostheses and Tricuspid ValvesPMA P860057replacement Heart-valvePMA P250019Prosthesis, mitral valve, percutaneously deliveredPMA P220003Mitral valve repair devicesPMA P200015Pulmonary valve prosthesis percutaneously deliveredPMA P150048heart-valve, non-allograft tissue

View all 81 devices →

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.

↑