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510(k) K843983

MYOCARDIAL INSULATOR by Norton Texas Medical Products — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1984
Date Received
October 11, 1984
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 Norton Texas Medical Products

  • K842194 — PRESSURE MONITOR (August 27, 1984)
  • K842992 — GRASSHOPPER - RETRACTOR (August 17, 1984)
  • K832517 — CUSTOM KWIK SET AND/OR PAK (October 14, 1983)

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  • 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)
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  • K173716 — MPS2 Myocardial Protection System Console (October 1, 2018)