FDA 510(k)

NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE

K-Number: K102919 · 2011-03-11

Decision Date2011-03-11

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE 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 2011-03-11 under 510(k) number K102919. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE?

NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE is a medical device that received FDA 510(k) clearance on 2011-03-11. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K102919.

When did NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE receive FDA 510(k) clearance?

NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE received FDA 510(k) clearance on 2011-03-11, under 510(k) number K102919.

Who is the listed applicant for NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE?

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 NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE?

The FDA product code for NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE is DTN.

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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 K132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS K131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING K130300HEATER-COOLER UNIT HCU 40 K123288HEMOCONCENTRATOR

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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.