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FDA 510(k)

ROTAFLOW CENTRIFUGAL PUMP SYSTEM

K-Number: K991864 · 2000-08-31

ApplicantJostra Medizintechnik AG
Decision Date2000-08-31
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ROTAFLOW CENTRIFUGAL PUMP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Jostra Medizintechnik AG. It received FDA 510(k) clearance on 2000-08-31 under 510(k) number K991864. 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 ROTAFLOW CENTRIFUGAL PUMP SYSTEM?

ROTAFLOW CENTRIFUGAL PUMP SYSTEM is a medical device that received FDA 510(k) clearance on 2000-08-31. The listed applicant is Jostra Medizintechnik AG. The 510(k) number is K991864.

When did ROTAFLOW CENTRIFUGAL PUMP SYSTEM receive FDA 510(k) clearance?

ROTAFLOW CENTRIFUGAL PUMP SYSTEM received FDA 510(k) clearance on 2000-08-31, under 510(k) number K991864.

Who is the listed applicant for ROTAFLOW CENTRIFUGAL PUMP SYSTEM?

The FDA 510(k) record lists Jostra Medizintechnik AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROTAFLOW CENTRIFUGAL PUMP SYSTEM?

The FDA product code for ROTAFLOW CENTRIFUGAL PUMP SYSTEM 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 Jostra Medizintechnik AG 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.

K001787QUART ARTERIAL FILTER, MODEL HBF 140

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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