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FDA 510(k)

MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR

K-Number: K004001 · 2001-10-04

ApplicantDideco
Decision Date2001-10-04
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dideco. It received FDA 510(k) clearance on 2001-10-04 under 510(k) number K004001. 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 MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR?

MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR is a medical device that received FDA 510(k) clearance on 2001-10-04. The listed applicant is Dideco. The 510(k) number is K004001.

When did MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR receive FDA 510(k) clearance?

MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR received FDA 510(k) clearance on 2001-10-04, under 510(k) number K004001.

Who is the listed applicant for MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR?

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

What is the FDA product code for MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR?

The FDA product code for MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR is DTZ.

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Other records listing Dideco 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.

K010478DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SURK001388DATA MASTER PERFUSION MONITORING SYSTEMK936220DIDECO VACUUM PUMPK940519DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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