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FDA 510(k)

INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER

K-Number: K874841 · 1988-02-02

ApplicantBentley Laboratories, Inc.
Decision Date1988-02-02
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1988-02-02 under 510(k) number K874841. 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 INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER?

INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K874841.

When did INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER receive FDA 510(k) clearance?

INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER received FDA 510(k) clearance on 1988-02-02, under 510(k) number K874841.

Who is the listed applicant for INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER?

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

What is the FDA product code for INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER?

The FDA product code for INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER is DTZ.

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Other records listing Bentley Laboratories, Inc. as applicant

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K931967HE-30 GOLDK913956BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30K913692VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)K903641QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000QK894826UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLFK874867CATR(TM)-H CARDIOTOMY HOLDER

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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

View on FDA Database →

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

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