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FDA 510(k)

PUMP, BYPASS, PULSATILE, AVCO

K-Number: K770937 · 1977-11-17

ApplicantAvco Medical Products
Decision Date1977-11-17
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PUMP, BYPASS, PULSATILE, AVCO is the device name listed in this FDA 510(k) record. The listed applicant is Avco Medical Products. It received FDA 510(k) clearance on 1977-11-17 under 510(k) number K770937. 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 PUMP, BYPASS, PULSATILE, AVCO?

PUMP, BYPASS, PULSATILE, AVCO is a medical device that received FDA 510(k) clearance on 1977-11-17. The listed applicant is Avco Medical Products. The 510(k) number is K770937.

When did PUMP, BYPASS, PULSATILE, AVCO receive FDA 510(k) clearance?

PUMP, BYPASS, PULSATILE, AVCO received FDA 510(k) clearance on 1977-11-17, under 510(k) number K770937.

Who is the listed applicant for PUMP, BYPASS, PULSATILE, AVCO?

The FDA 510(k) record lists Avco Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUMP, BYPASS, PULSATILE, AVCO?

The FDA product code for PUMP, BYPASS, PULSATILE, AVCO is KFM.

Related Clinical Trials

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.

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Other records listing Avco Medical Products 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.

K802924KONTRON PERCUTAEOUS DOUBLE-LUMENK790241INTRA-AORTIC BALLOON-PUMPK781848PUMP, BALLOON MODEL 10K770821PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT

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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