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510(k) K254279

Edwards eSheath+ introducer set by Edwards Lifesciences — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2026
Date Received
December 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Edwards Lifesciences

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  • K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900) (September 23, 2025)
  • K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450) (September 17, 2025)
  • K252364 — Edwards eSheath Optima introducer set (August 29, 2025)
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  • K242518 — Hypertension Prediction Index (HePI) Algorithm (May 15, 2025)
  • K244046 — Edwards eSheath Optima introducer set (March 27, 2025)
  • K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (March 21, 2025)

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  • K260459 — VANES Delivery System (VDS) (April 6, 2026)
  • K260626 — Multiflex Steerable Sheath 17.5F (March 26, 2026)
  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)