FDA 510(k)

TRILLIUM BIOPUMP PLUS, MODEL BPX80T

K-Number: K050109 · 2005-02-11

Decision Date2005-02-11

Product CodeKFM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TRILLIUM BIOPUMP PLUS, MODEL BPX80T is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Perfusion Systems. It received FDA 510(k) clearance on 2005-02-11 under 510(k) number K050109. 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 TRILLIUM BIOPUMP PLUS, MODEL BPX80T?

TRILLIUM BIOPUMP PLUS, MODEL BPX80T is a medical device that received FDA 510(k) clearance on 2005-02-11. The listed applicant is Medtronic Perfusion Systems. The 510(k) number is K050109.

When did TRILLIUM BIOPUMP PLUS, MODEL BPX80T receive FDA 510(k) clearance?

TRILLIUM BIOPUMP PLUS, MODEL BPX80T received FDA 510(k) clearance on 2005-02-11, under 510(k) number K050109.

Who is the listed applicant for TRILLIUM BIOPUMP PLUS, MODEL BPX80T?

The FDA 510(k) record lists Medtronic Perfusion Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRILLIUM BIOPUMP PLUS, MODEL BPX80T?

The FDA product code for TRILLIUM BIOPUMP PLUS, MODEL BPX80T is KFM.

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Related Devices (Code: KFM)

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.L K232132LifeSPARC SystemCardiacassist, Inc.K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsQura S.R.L K200091Capiox 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.