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FDA 510(k)

AB-180 XC SYSTEM, MODEL AB-180XC

K-Number: K991783 · 2000-11-01

ApplicantCardiacassist, Inc.
Decision Date2000-11-01
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AB-180 XC SYSTEM, MODEL AB-180XC is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2000-11-01 under 510(k) number K991783. 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 AB-180 XC SYSTEM, MODEL AB-180XC?

AB-180 XC SYSTEM, MODEL AB-180XC is a medical device that received FDA 510(k) clearance on 2000-11-01. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K991783.

When did AB-180 XC SYSTEM, MODEL AB-180XC receive FDA 510(k) clearance?

AB-180 XC SYSTEM, MODEL AB-180XC received FDA 510(k) clearance on 2000-11-01, under 510(k) number K991783.

Who is the listed applicant for AB-180 XC SYSTEM, MODEL AB-180XC?

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

What is the FDA product code for AB-180 XC SYSTEM, MODEL AB-180XC?

The FDA product code for AB-180 XC SYSTEM, MODEL AB-180XC is KFM.

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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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