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FDA 510(k)

CARDIOVENTION CORX SYSTEM, MODEL FG 0001

K-Number: K012325 · 2002-04-09

ApplicantCardiovention, Inc.
Decision Date2002-04-09
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVENTION CORX SYSTEM, MODEL FG 0001 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovention, Inc.. It received FDA 510(k) clearance on 2002-04-09 under 510(k) number K012325. 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 CARDIOVENTION CORX SYSTEM, MODEL FG 0001?

CARDIOVENTION CORX SYSTEM, MODEL FG 0001 is a medical device that received FDA 510(k) clearance on 2002-04-09. The listed applicant is Cardiovention, Inc.. The 510(k) number is K012325.

When did CARDIOVENTION CORX SYSTEM, MODEL FG 0001 receive FDA 510(k) clearance?

CARDIOVENTION CORX SYSTEM, MODEL FG 0001 received FDA 510(k) clearance on 2002-04-09, under 510(k) number K012325.

Who is the listed applicant for CARDIOVENTION CORX SYSTEM, MODEL FG 0001?

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

What is the FDA product code for CARDIOVENTION CORX SYSTEM, MODEL FG 0001?

The FDA product code for CARDIOVENTION CORX SYSTEM, MODEL FG 0001 is KFM.

Related Clinical Trials

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Other records listing Cardiovention, 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.

K032068CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200K030141MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100K021694CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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