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510(k) K260606

Echo Large Bore Introducer Sheath by Echo Medical, LLC — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2026
Date Received
February 24, 2026
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 for product code DYB

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  • K260091 — Aventus Introducer Sheath (April 13, 2026)
  • K260839 — Protaryx Transseptal Puncture Device (PTX2-001) (April 10, 2026)
  • K260942 — AuST Steerable Sheath (April 7, 2026)
  • 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)