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FDA 510(k)

Carpentier-Edwards Physio Annuloplasty Ring (4450)

K-Number: K251688 · 2025-09-17

ApplicantEdwards Lifesciences, LLC
Decision Date2025-09-17
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Carpentier-Edwards Physio Annuloplasty Ring (4450) is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2025-09-17 under approval number K251688. 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 Physio Annuloplasty Ring (4450)?

Carpentier-Edwards Physio Annuloplasty Ring (4450) is a medical device that received FDA 510(k) clearance on 2025-09-17. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K251688.

When was Carpentier-Edwards Physio Annuloplasty Ring (4450) approved by the FDA?

Carpentier-Edwards Physio Annuloplasty Ring (4450) received FDA 510(k) clearance on 2025-09-17, under approval number K251688.

What company makes Carpentier-Edwards Physio Annuloplasty Ring (4450)?

Carpentier-Edwards Physio Annuloplasty Ring (4450) is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Carpentier-Edwards Physio Annuloplasty Ring (4450)?

The FDA product code for Carpentier-Edwards Physio Annuloplasty Ring (4450) is KRH.

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Related Devices (Code: KRH)

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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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