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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 a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2019-12-16 under approval 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. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K192762.

When was Physio Flex Annuloplasty Ring approved by the FDA?

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

What company makes Physio Flex Annuloplasty Ring?

Physio Flex Annuloplasty Ring is manufactured by Edwards Lifesciences, LLC.

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

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

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Related Devices (Code: KRH)

K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandGenesee Biomedical, Inc. K181132Tri-Ad 2.0 Adams Tricuspid BandMedtronic K180411MEMO 4DSorin Group Italia S.R.L. K190506NeoForm Annuloplasty RingGenesee Biomedical, Inc. K202253TruForm Sievers Annuloplasty RingGenesee Biomedical, Inc. K201449SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty RingMedtronic, 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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