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510(k) K251688

Carpentier-Edwards Physio Annuloplasty Ring (4450) by Edwards Lifesciences, LLC — Product Code KRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2025
Date Received
June 2, 2025
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Annuloplasty
Device Class
Class II
Regulation Number
870.3800
Review Panel
CV
Submission Type

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  • K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphe (December 9, 2024)

Other clearances for product code KRH

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  • K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (July 25, 2025)
  • K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (April 9, 2024)
  • K230679 — WellsForm Tricuspid Annuloplasty Band (WF) (May 26, 2023)
  • K230318 — Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring (April 7, 2023)
  • K202253 — TruForm Sievers Annuloplasty Ring (October 6, 2020)
  • K201449 — SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuFo (July 1, 2020)
  • K192762 — Physio Flex Annuloplasty Ring (December 16, 2019)
  • K190506 — NeoForm Annuloplasty Ring (April 18, 2019)