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FDA 510(k)

SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION

K-Number: K912078 · 1991-08-20

Applicant3M Health Care, Sarns
Decision Date1991-08-20
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION 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 1991-08-20 under 510(k) number K912078. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION?

SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-08-20. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K912078.

When did SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION receive FDA 510(k) clearance?

SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION received FDA 510(k) clearance on 1991-08-20, under 510(k) number K912078.

Who is the listed applicant for SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION?

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 SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION?

The FDA product code for SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION is DTZ.

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Other records listing 3M Health Care, Sarns 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.

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: DTZ)

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.

K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.LK253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);Spectrum Medical S.R.L.K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.LK242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.LK231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura 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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