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510(k) K241708

Abiomed 14Fr Low Profile Introducer Kit by Abiomed, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2024
Date Received
June 13, 2024
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 Abiomed, Inc.

  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K221294 — preCARDIA Occlusion System (June 30, 2023)
  • K223161 — OXY-1 System (February 23, 2023)
  • K222113 — Abiomed 14Fr Low Profile Introducer Set (October 13, 2022)
  • K202330 — Impella XR Sheath Set (December 7, 2020)
  • K200109 — OXY-1 System (October 23, 2020)
  • K201116 — Abiomed 23 Fr Sheath (June 15, 2020)
  • K192769 — Impella CP Introducer (November 18, 2019)
  • K112892 — IMPELLA 2.5 PLUS CATHETER (September 6, 2012)
  • K110845 — IMPELLA CONTROLLER WITH FLOW CONTROL (April 27, 2011)

Other clearances for product code DYB

  • 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)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)