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FDA 510(k)

SCIMED ECMOTHERM(TM) HEAT EXCHANGER

K-Number: K884560 · 1989-04-03

ApplicantScimed Life Systems, Inc.
Decision Date1989-04-03
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED ECMOTHERM(TM) HEAT EXCHANGER is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1989-04-03 under 510(k) number K884560. 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 SCIMED ECMOTHERM(TM) HEAT EXCHANGER?

SCIMED ECMOTHERM(TM) HEAT EXCHANGER is a medical device that received FDA 510(k) clearance on 1989-04-03. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K884560.

When did SCIMED ECMOTHERM(TM) HEAT EXCHANGER receive FDA 510(k) clearance?

SCIMED ECMOTHERM(TM) HEAT EXCHANGER received FDA 510(k) clearance on 1989-04-03, under 510(k) number K884560.

Who is the listed applicant for SCIMED ECMOTHERM(TM) HEAT EXCHANGER?

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

What is the FDA product code for SCIMED ECMOTHERM(TM) HEAT EXCHANGER?

The FDA product code for SCIMED ECMOTHERM(TM) HEAT EXCHANGER is DTR.

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Other records listing Scimed Life Systems, Inc. as applicant

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.

K974241SCIMED INFORMER PRESSURE WIRE SYSTEMK981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERK980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRESK974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERSK974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERK973945LUGE GUIDE WIRE

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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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