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510(k) K232260

Thinline Sheath Introducer by Inneuroco, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2023
Date Received
July 31, 2023
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 Inneuroco, Inc.

  • K220331 — 091 Balloon Guide Catheter (July 29, 2022)
  • K190338 — 046 Zenith Flex (August 2, 2019)
  • K181354 — 074 Zenith Flex System (October 25, 2018)
  • K172167 — Zenith Flex System (April 19, 2018)
  • K173709 — Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm (January 26, 2018)
  • K172468 — 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm (December 6, 2017)
  • K171672 — 065 Zenith, 074 Zenith (October 19, 2017)
  • K161262 — Super Distal Access (SDA) (September 19, 2016)

Other clearances for product code DYB

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  • 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)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)