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FDA 510(k)

MECC SET WITH BIOLINE COATING

K-Number: K083794 · 2009-04-21

ApplicantMaquet Cardiopulmonary, AG
Decision Date2009-04-21
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MECC SET WITH BIOLINE COATING is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiopulmonary, AG. It received FDA 510(k) clearance on 2009-04-21 under 510(k) number K083794. 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 MECC SET WITH BIOLINE COATING?

MECC SET WITH BIOLINE COATING is a medical device that received FDA 510(k) clearance on 2009-04-21. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K083794.

When did MECC SET WITH BIOLINE COATING receive FDA 510(k) clearance?

MECC SET WITH BIOLINE COATING received FDA 510(k) clearance on 2009-04-21, under 510(k) number K083794.

Who is the listed applicant for MECC SET WITH BIOLINE COATING?

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

What is the FDA product code for MECC SET WITH BIOLINE COATING?

The FDA product code for MECC SET WITH BIOLINE COATING is KFM.

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Other records listing Maquet Cardiopulmonary, 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.

K133265QUADROX-IR ADULT AND SMALL ADULTK132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTK132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSK131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGK130300HEATER-COOLER UNIT HCU 40K123288HEMOCONCENTRATOR

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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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