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FDA 510(k)

DELPHIN II CENTRIFUGAL SYSTEM

K-Number: K913176 · 1991-11-07

Applicant3M Health Care, Sarns
Decision Date1991-11-07
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DELPHIN II CENTRIFUGAL 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 1991-11-07 under 510(k) number K913176. 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 DELPHIN II CENTRIFUGAL SYSTEM?

DELPHIN II CENTRIFUGAL SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K913176.

When did DELPHIN II CENTRIFUGAL SYSTEM receive FDA 510(k) clearance?

DELPHIN II CENTRIFUGAL SYSTEM received FDA 510(k) clearance on 1991-11-07, under 510(k) number K913176.

Who is the listed applicant for DELPHIN II CENTRIFUGAL 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 DELPHIN II CENTRIFUGAL SYSTEM?

The FDA product code for DELPHIN II CENTRIFUGAL SYSTEM is KFM.

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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: 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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