Home / 510(k) Clearances / K112892

510(k) K112892

IMPELLA 2.5 PLUS CATHETER by Abiomed, Inc. — Product Code PBL

K112892 is an FDA 510(k) premarket notification submitted by Abiomed, Inc. for the device "IMPELLA 2.5 PLUS CATHETER". The FDA issued a decision of SESU on September 6, 2012. Abiomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
September 6, 2012
Date Received
September 30, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Other clearances by Abiomed, Inc.

  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K241708 — Abiomed 14Fr Low Profile Introducer Kit (August 6, 2024)
  • 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)
  • K110845 — IMPELLA CONTROLLER WITH FLOW CONTROL (April 27, 2011)

FDA data resources