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510(k) K853791

NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 by Norton Performance Plastics Corp. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1985
Date Received
September 11, 1985
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 Performance Plastics Corp.

  • K852914 — ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION (September 25, 1985)
  • K851299 — CORRECT FLO (May 7, 1985)
  • K842858 — FLUID ADMINISTRATION LINE W/SPIKE 14-923 (September 11, 1984)
  • K841828 — CENTRAL VENOUS CATHETER W/BIG-GARD (July 13, 1984)
  • K840240 — MICROFUSE INTRAVENOUS CATHETER SET (April 17, 1984)
  • K831587 — TEMP. REPAIR KIT-DUAL LUMEN CATHETER (October 19, 1983)
  • K831698 — DISPOSABLE PRESSURE TRANSDUCER#14004195 (August 11, 1983)
  • K830788 — CENTRAL VEIN CATHERIZATION KIT-14-690- (April 30, 1983)
  • K830813 — FRENCH PERCUTANEOUS SHEATH INTRODUCER (April 28, 1983)
  • K830969 — PERM. REPAIR KIT FOR LEONARD NORTON DUAL (April 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)
  • K200438 — MPS 3 Myocardial Protection System (June 19, 2020)
  • K173716 — MPS2 Myocardial Protection System Console (October 1, 2018)