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FDA 510(k)

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700

K-Number: K030462 · 2003-03-06

ApplicantCobe Cardiovascular, Inc.
Decision Date2003-03-06
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Cardiovascular, Inc.. It received FDA 510(k) clearance on 2003-03-06 under 510(k) number K030462. 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 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700?

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 is a medical device that received FDA 510(k) clearance on 2003-03-06. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K030462.

When did COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 receive FDA 510(k) clearance?

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 received FDA 510(k) clearance on 2003-03-06, under 510(k) number K030462.

Who is the listed applicant for COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700?

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

What is the FDA product code for COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700?

The FDA product code for COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 is KFM.

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Other records listing Cobe Cardiovascular, Inc. 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.

K050111SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAGK042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMK040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTERK033641SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800K021830SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEMK011835COBE REVOLUTION

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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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