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510(k) K221373

Essenz HLM by Livanova Deutschland, GmbH — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2023
Date Received
May 12, 2022
Clearance Type
Traditional
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

  • K232291 — Essenz HLM, Essenz ILBM (August 24, 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

  • K232291 — Essenz HLM, Essenz ILBM (August 24, 2023)
  • K221895 — Terumo Advanced Perfusion System 1 (April 18, 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)