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510(k) K070213

PERFORMER CBP SYSTEM by Rand S.R.L. — Product Code DTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2007
Date Received
January 22, 2007
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 Rand S.R.L.

  • K161613 — Hang&Go PAC (December 28, 2016)
  • K120026 — PERFORMER HT/ HANG&GO HT BASIC (May 8, 2012)
  • K052555 — MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB (March 15, 2006)

Other clearances for product code DTQ

  • K232291 — Essenz HLM, Essenz ILBM (August 24, 2023)
  • 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)