Myocardial Insulator

FDA 510(k) K843983 · Norton Texas Medical Products

Substantially Equivalent

510(k) numberK843983

Submission

Device name
Myocardial Insulator
Applicant
Norton Texas Medical Products
Houston, TX, US
Received
October 11, 1984
Decision date
December 27, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DTR – Heat-Exchanger, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4240
Specialty
Cardiovascular
Life-sustaining
Yes

Other 510(k)s with product code DTR

510(k)DeviceApplicantDecision
K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WDTR · Traditional Spectrum Medical S.R.L.03/12/2026SE
K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module…DTR · Traditional Spectrum Medical , Ltd.07/08/2025SE
K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special Sorin Group Italia S.R.L.05/30/2025SE
K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…DTR · Special Medtronic02/23/2024SE
K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)DTR · Special Quara S.R.L.04/13/2023SE
K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional Qura S.R.L05/06/2022SE
K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional Qura S.R.L01/10/2022SE
K201984MPS 3 ND Myocardial Protection SystemDTR · Traditional Quest Medical, Inc.11/20/2020SE
K200438MPS 3 Myocardial Protection SystemDTR · Traditional Quest Medical, Inc.06/19/2020SE
K173716MPS2 Myocardial Protection System ConsoleDTR · Traditional Quest Medical, Inc.10/01/2018SE

More from Quest Medical, Inc.

510(k)DeviceDecision
K842194Pressure MonitorDXS · Traditional 08/27/1984SE
K842992Grasshopper - RetractorGAD · Traditional 08/17/1984SE
K832517Custom Kwik Set And/Or PakJOL · Traditional 10/14/1983SE

Questions and answers

When was Myocardial Insulator cleared by the FDA?

Myocardial Insulator (K843983) received a 510(k) decision of Substantially Equivalent on December 27, 1984, 77 days after the submission was received.

What is the product code of K843983?

The FDA product code is DTR – Heat-Exchanger, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4240.