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FDA 510(k)

LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052

K-Number: K090051 · 2009-10-08

ApplicantLevitronix, LLC
Decision Date2009-10-08
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 is the device name listed in this FDA 510(k) record. The listed applicant is Levitronix, LLC. It received FDA 510(k) clearance on 2009-10-08 under 510(k) number K090051. 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 LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052?

LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 is a medical device that received FDA 510(k) clearance on 2009-10-08. The listed applicant is Levitronix, LLC. The 510(k) number is K090051.

When did LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 receive FDA 510(k) clearance?

LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 received FDA 510(k) clearance on 2009-10-08, under 510(k) number K090051.

Who is the listed applicant for LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052?

The FDA 510(k) record lists Levitronix, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052?

The FDA product code for LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 is KFM.

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Other records listing Levitronix, LLC 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.

K110983CENTRIMAG DRAINAGE CANNULA KITK110980CENTRIMAG RETURN CANNULA KITK102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITORK093832LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLESK090004LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLESK083340LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE

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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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