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FDA 510(k)

JOSTRA MECC SYSTEM

K-Number: K023132 · 2002-12-17

ApplicantJostra AG
Decision Date2002-12-17
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

JOSTRA MECC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Jostra AG. It received FDA 510(k) clearance on 2002-12-17 under 510(k) number K023132. 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 JOSTRA MECC SYSTEM?

JOSTRA MECC SYSTEM is a medical device that received FDA 510(k) clearance on 2002-12-17. The listed applicant is Jostra AG. The 510(k) number is K023132.

When did JOSTRA MECC SYSTEM receive FDA 510(k) clearance?

JOSTRA MECC SYSTEM received FDA 510(k) clearance on 2002-12-17, under 510(k) number K023132.

Who is the listed applicant for JOSTRA MECC SYSTEM?

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

What is the FDA product code for JOSTRA MECC SYSTEM?

The FDA product code for JOSTRA MECC SYSTEM is KFM.

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Other records listing Jostra 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.

K020983JOSTRA SUCKERS, MODEL JSK030264QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030K020784JOSTRA SINGLE STAGE VENOUS RETURN CATHETERSK022022JOSTRA VENT CATHETERS, MODELS LV & HKVK020515JOSTRA ANTEGRADE CARDIOPLEGIA CANNULAK014303JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE

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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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