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FDA 510(k)

VISION HOLLOW FIBER OXYGENATOR WITH HA COATING

K-Number: K080708 · 2009-02-02

ApplicantGish Biomedical, Inc.
Decision Date2009-02-02
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VISION HOLLOW FIBER OXYGENATOR WITH HA COATING is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 2009-02-02 under 510(k) number K080708. 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 VISION HOLLOW FIBER OXYGENATOR WITH HA COATING?

VISION HOLLOW FIBER OXYGENATOR WITH HA COATING is a medical device that received FDA 510(k) clearance on 2009-02-02. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K080708.

When did VISION HOLLOW FIBER OXYGENATOR WITH HA COATING receive FDA 510(k) clearance?

VISION HOLLOW FIBER OXYGENATOR WITH HA COATING received FDA 510(k) clearance on 2009-02-02, under 510(k) number K080708.

Who is the listed applicant for VISION HOLLOW FIBER OXYGENATOR WITH HA COATING?

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

What is the FDA product code for VISION HOLLOW FIBER OXYGENATOR WITH HA COATING?

The FDA product code for VISION HOLLOW FIBER OXYGENATOR WITH HA COATING is DTZ.

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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

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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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