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FDA 510(k)

D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR

K-Number: K020351 · 2002-02-26

ApplicantDideco S.P.A.
Decision Date2002-02-26
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dideco S.P.A.. It received FDA 510(k) clearance on 2002-02-26 under 510(k) number K020351. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR?

D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR is a medical device that received FDA 510(k) clearance on 2002-02-26. The listed applicant is Dideco S.P.A.. The 510(k) number is K020351.

When did D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR receive FDA 510(k) clearance?

D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR received FDA 510(k) clearance on 2002-02-26, under 510(k) number K020351.

Who is the listed applicant for D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR?

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

What is the FDA product code for D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR?

The FDA product code for D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR is DTZ.

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Other records listing Dideco S.P.A. 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.

K041061D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERSK033323D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATINGK033987D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERSK033714MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATINGK032040IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATORK031223SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR

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Related Devices (Code: DTZ)

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.

K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.LK253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);Spectrum Medical S.R.L.K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.LK242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.LK231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.L

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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