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510(k) K192762

Physio Flex Annuloplasty Ring by Edwards Lifesciences, LLC — Product Code KRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2019
Date Received
September 30, 2019
Clearance Type
Traditional
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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Other clearances for product code KRH

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  • K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF) (July 25, 2025)
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  • 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)
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