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510(k) K201116

Abiomed 23 Fr Sheath by Abiomed, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2020
Date Received
April 27, 2020
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

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  • K200109 — OXY-1 System (October 23, 2020)
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  • K112892 — IMPELLA 2.5 PLUS CATHETER (September 6, 2012)
  • K110845 — IMPELLA CONTROLLER WITH FLOW CONTROL (April 27, 2011)

Other clearances for product code DYB

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  • 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)