FDA 510(k)

SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION

K-Number: K941653 · 1994-08-24

Decision Date1994-08-24

Product CodeDTZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SARNS TURBO 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 1994-08-24 under 510(k) number K941653. 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 TURBO MEMBRANE OXYGENATOR MODIFICATION?

SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-08-24. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K941653.

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

SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION received FDA 510(k) clearance on 1994-08-24, under 510(k) number K941653.

Who is the listed applicant for SARNS TURBO 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 TURBO MEMBRANE OXYGENATOR MODIFICATION?

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

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Other records listing 3M Health Care, Sarns as applicant

K960916SAMS 8000 CARDIOPLEGIA MONITOR K953901SARNS 800 ROLLER PUMP K9507393M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM K941654SARNS FILTERED VENOUS RESERVIOR MODIFICATION K940651SARNS ULTRASONIC AIR SENSOR K935391SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK

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Related Devices (Code: DTZ)

K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L K253838Lifemotion 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.L K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L K231982Quantum 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.