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FDA 510(k)

MODIFIED CARDIOTOMY RESERVOIR 5M1470

K-Number: K862357 · 1986-08-19

Applicant3M Health Care, Sarns
Decision Date1986-08-19
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED CARDIOTOMY RESERVOIR 5M1470 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 1986-08-19 under 510(k) number K862357. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED CARDIOTOMY RESERVOIR 5M1470?

MODIFIED CARDIOTOMY RESERVOIR 5M1470 is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K862357.

When did MODIFIED CARDIOTOMY RESERVOIR 5M1470 receive FDA 510(k) clearance?

MODIFIED CARDIOTOMY RESERVOIR 5M1470 received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862357.

Who is the listed applicant for MODIFIED CARDIOTOMY RESERVOIR 5M1470?

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 MODIFIED CARDIOTOMY RESERVOIR 5M1470?

The FDA product code for MODIFIED CARDIOTOMY RESERVOIR 5M1470 is DTN.

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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: DTN)

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.

K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac SurgeryK223361BMR 1900 PHISIOSorin Group Italia S.R.L.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia 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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