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FDA 510(k)

CENTRIFUGAL PUMP SYSTEM LX/DX VERSION

K-Number: K882758 · 1988-10-13

Applicant3M Health Care, Sarns
Decision Date1988-10-13
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTRIFUGAL PUMP SYSTEM LX/DX VERSION 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 1988-10-13 under 510(k) number K882758. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIFUGAL PUMP SYSTEM LX/DX VERSION?

CENTRIFUGAL PUMP SYSTEM LX/DX VERSION is a medical device that received FDA 510(k) clearance on 1988-10-13. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K882758.

When did CENTRIFUGAL PUMP SYSTEM LX/DX VERSION receive FDA 510(k) clearance?

CENTRIFUGAL PUMP SYSTEM LX/DX VERSION received FDA 510(k) clearance on 1988-10-13, under 510(k) number K882758.

Who is the listed applicant for CENTRIFUGAL PUMP SYSTEM LX/DX VERSION?

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 CENTRIFUGAL PUMP SYSTEM LX/DX VERSION?

The FDA product code for CENTRIFUGAL PUMP SYSTEM LX/DX VERSION is KFM.

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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: KFM)

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.

K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)Spectrum Medical S.R.L.K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)Qura S.R.LK232132LifeSPARC SystemCardiacassist, Inc.K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsQura S.R.LK200091Capiox iCP Centrifugal PumpTerumo Cardiovascular Systems Corporation

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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