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510(k) K261492

FieldFlex Steerable Sheath by CenterPoint Systems, LLC — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2026
Date Received
May 6, 2026
Clearance Type
Special
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

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  • K243180 — SSPC NXT Delivery Catheter (December 4, 2024)
  • K242106 — AuST Steerable Sheath (October 4, 2024)
  • K233752 — Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ I (May 2, 2024)
  • K240829 — AuST Steerable Sheath (May 1, 2024)

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)