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FDA 510(k)

CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100

K-Number: K870804 · 1987-09-01

ApplicantAmerican Bentley
Decision Date1987-09-01
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPLEGIA HEAT EXCHANGER MODEL NO. 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 1987-09-01 under 510(k) number K870804. 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 MODEL NO. HE-100?

CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 is a medical device that received FDA 510(k) clearance on 1987-09-01. The listed applicant is American Bentley. The 510(k) number is K870804.

When did CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 receive FDA 510(k) clearance?

CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 received FDA 510(k) clearance on 1987-09-01, under 510(k) number K870804.

Who is the listed applicant for CARDIOPLEGIA HEAT EXCHANGER MODEL NO. 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 MODEL NO. HE-100?

The FDA product code for CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 is DTR.

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Other records listing American Bentley as applicant

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K872896UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100K873923INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTERK872167CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500K872133OXYGENATOR MODEL NO. BENTLEY 5 PLUSK870911INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALYK870269ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100

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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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