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FDA 510(k)

BLOOD OXYGENATOR 50 70/S

K-Number: K831895 · 1983-10-19

ApplicantShiley, Inc.
Decision Date1983-10-19
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLOOD OXYGENATOR 50 70/S is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1983-10-19 under 510(k) number K831895. 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 BLOOD OXYGENATOR 50 70/S?

BLOOD OXYGENATOR 50 70/S is a medical device that received FDA 510(k) clearance on 1983-10-19. The listed applicant is Shiley, Inc.. The 510(k) number is K831895.

When did BLOOD OXYGENATOR 50 70/S receive FDA 510(k) clearance?

BLOOD OXYGENATOR 50 70/S received FDA 510(k) clearance on 1983-10-19, under 510(k) number K831895.

Who is the listed applicant for BLOOD OXYGENATOR 50 70/S?

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

What is the FDA product code for BLOOD OXYGENATOR 50 70/S?

The FDA product code for BLOOD OXYGENATOR 50 70/S is DTZ.

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Other records listing Shiley, Inc. as applicant

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K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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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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