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FDA 510(k)

PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR

K-Number: K901249 · 1990-06-11

ApplicantShiley, Inc.
Decision Date1990-06-11
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1990-06-11 under 510(k) number K901249. 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 PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR?

PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR is a medical device that received FDA 510(k) clearance on 1990-06-11. The listed applicant is Shiley, Inc.. The 510(k) number is K901249.

When did PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR receive FDA 510(k) clearance?

PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR received FDA 510(k) clearance on 1990-06-11, under 510(k) number K901249.

Who is the listed applicant for PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR?

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 PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR?

The FDA product code for PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR is DTZ.

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Other records listing Shiley, Inc. as applicant

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.

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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