Carpentier-Edwards Physio Annuloplasty Ring (4450)— 510(k) K251688

Name: FDA 510(k) clearance K251688
Creator: U.S. Food and Drug Administration
Published: 2025-09-17

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K251688 for Carpentier-Edwards Physio Annuloplasty Ring (4450), Substantially Equivalent on 2025-09-17. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code KRH
Device class: Class 2
Regulation: 21 CFR 870.3800
Advisory panel: Cardiovascular
Date received: 2025-06-02
Decision date: 2025-09-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRH

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K261707 — MEMO 4D Curve Semirigid mitral annuloplasty ring2026-06-18
K260498 — TriMemo SEMIRIGID ANNULOPLASTY RING2026-04-14
K253232 — Seguin Annuloplasty Ring2025-10-29
K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)2025-09-23
K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF)2025-07-25

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K253186 — HemoSphere Nano Monitor (HSNANO1)2026-02-24
K242518 — Hypertension Prediction Index (HePI) Algorithm2025-05-15
K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors2025-03-21
K240078 — Fogarty Thru-Lumen Embolectomy Catheter2024-08-28

Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.