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FDA 510(k)

CARDIOPLEGIA DELIVERY SYSTEM

K-Number: K800377 · 1980-03-19

Applicant3M Health Care, Sarns
Decision Date1980-03-19
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPLEGIA DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Sarns. It received FDA 510(k) clearance on 1980-03-19 under 510(k) number K800377. 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 DELIVERY SYSTEM?

CARDIOPLEGIA DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1980-03-19. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K800377.

When did CARDIOPLEGIA DELIVERY SYSTEM receive FDA 510(k) clearance?

CARDIOPLEGIA DELIVERY SYSTEM received FDA 510(k) clearance on 1980-03-19, under 510(k) number K800377.

Who is the listed applicant for CARDIOPLEGIA DELIVERY SYSTEM?

The FDA 510(k) record lists 3M Health Care, Sarns as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOPLEGIA DELIVERY SYSTEM?

The FDA product code for CARDIOPLEGIA DELIVERY SYSTEM is DTR.

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Other records listing 3M Health Care, Sarns as applicant

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K960916SAMS 8000 CARDIOPLEGIA MONITORK953901SARNS 800 ROLLER PUMPK9507393M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEMK941653SARNS TURBO MEMBRANE OXYGENATOR MODIFICATIONK941654SARNS FILTERED VENOUS RESERVIOR MODIFICATIONK940651SARNS ULTRASONIC AIR SENSOR

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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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