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FDA 510(k)

BPX80 BIO-PUMP (BPX80)

K-Number: K973011 · 1998-02-25

ApplicantMedtronic Bio-Medicus, Inc.
Decision Date1998-02-25
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BPX80 BIO-PUMP (BPX80) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Bio-Medicus, Inc.. It received FDA 510(k) clearance on 1998-02-25 under 510(k) number K973011. 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 BPX80 BIO-PUMP (BPX80)?

BPX80 BIO-PUMP (BPX80) is a medical device that received FDA 510(k) clearance on 1998-02-25. The listed applicant is Medtronic Bio-Medicus, Inc.. The 510(k) number is K973011.

When did BPX80 BIO-PUMP (BPX80) receive FDA 510(k) clearance?

BPX80 BIO-PUMP (BPX80) received FDA 510(k) clearance on 1998-02-25, under 510(k) number K973011.

Who is the listed applicant for BPX80 BIO-PUMP (BPX80)?

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

What is the FDA product code for BPX80 BIO-PUMP (BPX80)?

The FDA product code for BPX80 BIO-PUMP (BPX80) is KFM.

Other records listing Medtronic Bio-Medicus, 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.

K973237CSS-CARDIOPLEGIA SAFETY SYSTEMK954501BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEMK941922MEDSAT OXYGEN SATURATION SYSTEMK936091MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLERK941921BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550K924208BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)

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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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