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FDA 510(k)

LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

K-Number: K953835 · 1996-03-15

ApplicantDideco S.R.L.
Decision Date1996-03-15
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR 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 1996-03-15 under 510(k) number K953835. 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 LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR?

LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR is a medical device that received FDA 510(k) clearance on 1996-03-15. The listed applicant is Dideco S.R.L.. The 510(k) number is K953835.

When did LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR receive FDA 510(k) clearance?

LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR received FDA 510(k) clearance on 1996-03-15, under 510(k) number K953835.

Who is the listed applicant for LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR?

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 LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR?

The FDA product code for LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR is DTZ.

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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 FILTERK050890ECC.O SYSTEMK050447PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATORK043323D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

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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