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FDA 510(k)

MINIPRIME HYPOTHERMIC HEAT EXCHANGER

K-Number: K791430 · 1979-08-28

ApplicantTravenol Laboratories, S.A.
Decision Date1979-08-28
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINIPRIME HYPOTHERMIC HEAT EXCHANGER is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1979-08-28 under 510(k) number K791430. 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 MINIPRIME HYPOTHERMIC HEAT EXCHANGER?

MINIPRIME HYPOTHERMIC HEAT EXCHANGER is a medical device that received FDA 510(k) clearance on 1979-08-28. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K791430.

When did MINIPRIME HYPOTHERMIC HEAT EXCHANGER receive FDA 510(k) clearance?

MINIPRIME HYPOTHERMIC HEAT EXCHANGER received FDA 510(k) clearance on 1979-08-28, under 510(k) number K791430.

Who is the listed applicant for MINIPRIME HYPOTHERMIC HEAT EXCHANGER?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINIPRIME HYPOTHERMIC HEAT EXCHANGER?

The FDA product code for MINIPRIME HYPOTHERMIC HEAT EXCHANGER 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

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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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