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FDA 510(k)

A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000

K-Number: K992592 · 2000-05-04

ApplicantA-Med Systems, Inc.
Decision Date2000-05-04
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 is the device name listed in this FDA 510(k) record. The listed applicant is A-Med Systems, Inc.. It received FDA 510(k) clearance on 2000-05-04 under 510(k) number K992592. 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 A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000?

A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 is a medical device that received FDA 510(k) clearance on 2000-05-04. The listed applicant is A-Med Systems, Inc.. The 510(k) number is K992592.

When did A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 receive FDA 510(k) clearance?

A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 received FDA 510(k) clearance on 2000-05-04, under 510(k) number K992592.

Who is the listed applicant for A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000?

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

What is the FDA product code for A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000?

The FDA product code for A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing A-Med Systems, 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.

K020529LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2K013393HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1HK991541A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44

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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