Cardiovention Corx System, Model FG 0001

Q: What is the product code of K012325?

The FDA product code is KFM – Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4360.

FDA 510(k) K012325 · Cardiovention, Inc.

Substantially Equivalent

510(k) numberK012325

Submission

Device name: Cardiovention Corx System, Model FG 0001
Applicant: Cardiovention, Inc.
Santa Clara, CA, US
Received: July 23, 2001
Decision date: April 9, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KFM – Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.4360
Specialty: Cardiovascular

Other 510(k)s with product code KFM

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K251762	Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)KFM · Traditional	Spectrum Medical S.R.L.	08/04/2025SE
K250326	Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)KFM · Traditional	Spectrum Medical S.R.L.	06/24/2025SE
K233091	Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)…KFM · Special	Qura S.R.L	10/26/2023SE
K232132	LifeSPARC SystemKFM · Special	Cardiacassist, Inc.	08/03/2023SE
K220842	Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion…KFM · Traditional	Qura S.R.L	05/19/2023SE
K200091	Capiox iCP Centrifugal PumpKFM · Traditional	Terumo Cardiovascular Systems Corporation	11/18/2021SE
K201320	Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorKFM · Traditional	Qura S.R.L	11/03/2021SE
K193663	FloPump 57mL Centrifugal PumpKFM · Traditional	International Biophysics Corporation	03/10/2021SE
K202169	Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22KFM · Special	Qura S.R.L	09/02/2020SE
K201068	Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance…KFM · Special	Medtronic, Inc.	05/21/2020SE

More from Medtronic, Inc.

510(k)	Device	Decision
K032068	Cardiovention Corx IOS-200 System, Model IOS-200DTR · Traditional	08/22/2003SE
K030141	Modification to Cardiovention Powerbase Console, Model PCB-100DTQ · Special	02/26/2003SE
K021694	Cardiovention Powerbase Console, Model PBC-100DTQ · Traditional	01/08/2003SE

Questions and answers

When was Cardiovention Corx System, Model FG 0001 cleared by the FDA?

Cardiovention Corx System, Model FG 0001 (K012325) received a 510(k) decision of Substantially Equivalent on April 9, 2002, 260 days after the submission was received.

What is the product code of K012325?

The FDA product code is KFM – Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4360.