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FDA 510(k)

QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING

K-Number: K103191 · 2011-03-08

ApplicantMaquet Cardiopulmonary, AG
Decision Date2011-03-08
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiopulmonary, AG. It received FDA 510(k) clearance on 2011-03-08 under 510(k) number K103191. 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 QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING?

QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING is a medical device that received FDA 510(k) clearance on 2011-03-08. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K103191.

When did QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING receive FDA 510(k) clearance?

QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING received FDA 510(k) clearance on 2011-03-08, under 510(k) number K103191.

Who is the listed applicant for QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING?

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

What is the FDA product code for QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING?

The FDA product code for QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING is DTZ.

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Other records listing Maquet Cardiopulmonary, AG 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.

K133265QUADROX-IR ADULT AND SMALL ADULTK132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTK132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSK131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGK130300HEATER-COOLER UNIT HCU 40K123288HEMOCONCENTRATOR

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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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