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FDA 510(k)

BASIC HEATER-COOLER UNIT, 115/100V 16-02-20

K-Number: K883330 · 1988-09-26

ApplicantShiley, Inc.
Decision Date1988-09-26
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1988-09-26 under 510(k) number K883330. 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 BASIC HEATER-COOLER UNIT, 115/100V 16-02-20?

BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 is a medical device that received FDA 510(k) clearance on 1988-09-26. The listed applicant is Shiley, Inc.. The 510(k) number is K883330.

When did BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 receive FDA 510(k) clearance?

BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 received FDA 510(k) clearance on 1988-09-26, under 510(k) number K883330.

Who is the listed applicant for BASIC HEATER-COOLER UNIT, 115/100V 16-02-20?

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

What is the FDA product code for BASIC HEATER-COOLER UNIT, 115/100V 16-02-20?

The FDA product code for BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 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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