FDA 510(k)

APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

K-Number: K092895 · 2009-10-19

Decision Date2009-10-19

Product CodeDTZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2009-10-19 under 510(k) number K092895. 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 APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR?

APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR is a medical device that received FDA 510(k) clearance on 2009-10-19. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K092895.

When did APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR receive FDA 510(k) clearance?

APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR received FDA 510(k) clearance on 2009-10-19, under 510(k) number K092895.

Who is the listed applicant for APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR?

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

What is the FDA product code for APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR?

The FDA product code for APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR is DTZ.

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Related Devices (Code: DTZ)

K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L K253838Lifemotion 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.L K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L K231982Quantum 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.