FDA 510(k)

QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS

K-Number: K132829 · 2013-10-08

Decision Date2013-10-08

Product CodeDTZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS 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 2013-10-08 under 510(k) number K132829. 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, QUADROX-ID, QUADROX-IR OXYGENATORS?

QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS is a medical device that received FDA 510(k) clearance on 2013-10-08. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K132829.

When did QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS receive FDA 510(k) clearance?

QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS received FDA 510(k) clearance on 2013-10-08, under 510(k) number K132829.

Who is the listed applicant for QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS?

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, QUADROX-ID, QUADROX-IR OXYGENATORS?

The FDA product code for QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS is DTZ.

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Other records listing Maquet Cardiopulmonary, AG as applicant

K133265QUADROX-IR ADULT AND SMALL ADULT K132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT K131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING K130300HEATER-COOLER UNIT HCU 40 K123288HEMOCONCENTRATOR K130639ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER

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Related Devices (Code: DTZ)

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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.