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510(k) K173716

MPS2 Myocardial Protection System Console by Quest Medical, Inc. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2018
Date Received
December 5, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat-Exchanger, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4240
Review Panel
CV
Submission Type

Other clearances by Quest Medical, Inc.

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  • K213846 — Q2 Blood Administration Sets (June 5, 2022)
  • K213588 — Q2 IV Administration Sets (June 2, 2022)
  • K202672 — Precision Delivery Infusion Set (January 21, 2021)
  • K201984 — MPS 3 ND Myocardial Protection System (November 20, 2020)
  • K200438 — MPS 3 Myocardial Protection System (June 19, 2020)
  • K182442 — MiniGuard Arterial Safety Valve (November 6, 2018)
  • K162804 — Q2 Low Pressure Power Injection Extension Set (March 8, 2017)
  • K162304 — Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV A (December 6, 2016)
  • K151079 — Q2 Intravenous Adminstration Sets and Extension Sets (September 30, 2015)

Other clearances for product code DTR

  • K252541 — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (March 12, 2026)
  • K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery (July 8, 2025)
  • K250150 — VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGU (May 30, 2025)
  • K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOther (February 23, 2024)
  • K223879 — Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) (April 13, 2023)
  • K220110 — Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat (May 6, 2022)
  • K212688 — Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exc (January 10, 2022)
  • K201984 — MPS 3 ND Myocardial Protection System (November 20, 2020)
  • K200438 — MPS 3 Myocardial Protection System (June 19, 2020)
  • K162774 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOther (February 10, 2017)