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FDA 510(k)

EXTRACORPOREAL HEAT EXCHANGER HE SERIES

K-Number: K896020 · 1990-05-17

ApplicantGish Biomedical, Inc.
Decision Date1990-05-17
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTRACORPOREAL HEAT EXCHANGER HE SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1990-05-17 under 510(k) number K896020. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRACORPOREAL HEAT EXCHANGER HE SERIES?

EXTRACORPOREAL HEAT EXCHANGER HE SERIES is a medical device that received FDA 510(k) clearance on 1990-05-17. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K896020.

When did EXTRACORPOREAL HEAT EXCHANGER HE SERIES receive FDA 510(k) clearance?

EXTRACORPOREAL HEAT EXCHANGER HE SERIES received FDA 510(k) clearance on 1990-05-17, under 510(k) number K896020.

Who is the listed applicant for EXTRACORPOREAL HEAT EXCHANGER HE SERIES?

The FDA 510(k) record lists Gish Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTRACORPOREAL HEAT EXCHANGER HE SERIES?

The FDA product code for EXTRACORPOREAL HEAT EXCHANGER HE SERIES is DTR.

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Related Devices (Code: DTR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)Spectrum Medical , Ltd.K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)Sorin Group Italia S.R.L.K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System UncoatedMedtronicK223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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