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FDA 510(k)

ECC.O SYSTEM

K-Number: K050890 · 2005-05-05

ApplicantDideco S.R.L.
Decision Date2005-05-05
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECC.O SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dideco S.R.L.. It received FDA 510(k) clearance on 2005-05-05 under 510(k) number K050890. 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 ECC.O SYSTEM?

ECC.O SYSTEM is a medical device that received FDA 510(k) clearance on 2005-05-05. The listed applicant is Dideco S.R.L.. The 510(k) number is K050890.

When did ECC.O SYSTEM receive FDA 510(k) clearance?

ECC.O SYSTEM received FDA 510(k) clearance on 2005-05-05, under 510(k) number K050890.

Who is the listed applicant for ECC.O SYSTEM?

The FDA 510(k) record lists Dideco S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECC.O SYSTEM?

The FDA product code for ECC.O 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 Dideco S.R.L. 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.

K052717D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTERK051232D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTERK050447PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATORK043323D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIRK953835LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

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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