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FDA 510(k)

MEMBRANE OXYGENATOR

K-Number: K882892 · 1988-09-27

ApplicantBaxter Bentley Laboratories, Inc.
Decision Date1988-09-27
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEMBRANE OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1988-09-27 under 510(k) number K882892. 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 MEMBRANE OXYGENATOR?

MEMBRANE OXYGENATOR is a medical device that received FDA 510(k) clearance on 1988-09-27. The listed applicant is Baxter Bentley Laboratories, Inc.. The 510(k) number is K882892.

When did MEMBRANE OXYGENATOR receive FDA 510(k) clearance?

MEMBRANE OXYGENATOR received FDA 510(k) clearance on 1988-09-27, under 510(k) number K882892.

Who is the listed applicant for MEMBRANE OXYGENATOR?

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

What is the FDA product code for MEMBRANE OXYGENATOR?

The FDA product code for MEMBRANE OXYGENATOR is DTZ.

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Other records listing Baxter Bentley Laboratories, Inc. as applicant

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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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