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FDA 510(k)

HEAT EXCHANGER, DISP., OMNITHERM

K-Number: K772117 · 1978-03-02

ApplicantScimed Life Systems, Inc.
Decision Date1978-03-02
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEAT EXCHANGER, DISP., OMNITHERM 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 1978-03-02 under 510(k) number K772117. 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 HEAT EXCHANGER, DISP., OMNITHERM?

HEAT EXCHANGER, DISP., OMNITHERM is a medical device that received FDA 510(k) clearance on 1978-03-02. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K772117.

When did HEAT EXCHANGER, DISP., OMNITHERM receive FDA 510(k) clearance?

HEAT EXCHANGER, DISP., OMNITHERM received FDA 510(k) clearance on 1978-03-02, under 510(k) number K772117.

Who is the listed applicant for HEAT EXCHANGER, DISP., OMNITHERM?

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 HEAT EXCHANGER, DISP., OMNITHERM?

The FDA product code for HEAT EXCHANGER, DISP., OMNITHERM is DTR.

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Other records listing Scimed Life Systems, Inc. as applicant

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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

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

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