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FDA 510(k)

CARDIOPLEGIA HEAT EXCHANGER HE-100

K-Number: K840045 · 1984-02-13

ApplicantAmerican Bentley
Decision Date1984-02-13
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPLEGIA HEAT EXCHANGER HE-100 is the device name listed in this FDA 510(k) record. The listed applicant is American Bentley. It received FDA 510(k) clearance on 1984-02-13 under 510(k) number K840045. 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 CARDIOPLEGIA HEAT EXCHANGER HE-100?

CARDIOPLEGIA HEAT EXCHANGER HE-100 is a medical device that received FDA 510(k) clearance on 1984-02-13. The listed applicant is American Bentley. The 510(k) number is K840045.

When did CARDIOPLEGIA HEAT EXCHANGER HE-100 receive FDA 510(k) clearance?

CARDIOPLEGIA HEAT EXCHANGER HE-100 received FDA 510(k) clearance on 1984-02-13, under 510(k) number K840045.

Who is the listed applicant for CARDIOPLEGIA HEAT EXCHANGER HE-100?

The FDA 510(k) record lists American Bentley as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOPLEGIA HEAT EXCHANGER HE-100?

The FDA product code for CARDIOPLEGIA HEAT EXCHANGER HE-100 is DTR.

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Other records listing American Bentley as applicant

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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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