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510(k) K232291

Essenz HLM, Essenz ILBM by Livanova Deutschland, GmbH — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2023
Date Received
August 1, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4220
Review Panel
CV
Submission Type

Other clearances by Livanova Deutschland, GmbH

  • K221373 — Essenz HLM (March 9, 2023)
  • K220635 — Heater-Cooler System 3T (November 16, 2022)
  • K212003 — ESSENZ Patient Monitor (November 10, 2021)
  • K210130 — Stockert S5 System (April 5, 2021)
  • K202154 — B-Capta (April 1, 2021)
  • K191402 — Heater-Cooler System 3T (February 25, 2020)

Other clearances for product code DTQ

  • K221895 — Terumo Advanced Perfusion System 1 (April 18, 2023)
  • K221373 — Essenz HLM (March 9, 2023)
  • K210130 — Stockert S5 System (April 5, 2021)
  • K202125 — Century Perfusion System (March 7, 2021)
  • K190282 — Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (May 24, 2019)
  • K173834 — Quantum Pump Console (May 25, 2018)
  • K172220 — Advanced Perfusion System 1 (August 17, 2017)
  • K163531 — Advanced Perfusion System 1 (June 7, 2017)
  • K153376 — Advanced Perfusion System 1 (December 16, 2015)
  • K151349 — Advanced Perfusion System 1 (August 27, 2015)