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FDA 510(k)

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

K-Number: K241849 · 2024-11-05

Decision Date2024-11-05
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) is a medical device manufactured by Imaxeon Pty, Ltd.. It received FDA 510(k) clearance on 2024-11-05 under approval number K241849. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)?

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) is a medical device that received FDA 510(k) clearance on 2024-11-05. It is manufactured by Imaxeon Pty, Ltd.. The 510(k) number is K241849.

When was MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) approved by the FDA?

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) received FDA 510(k) clearance on 2024-11-05, under approval number K241849.

What company makes MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)?

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) is manufactured by Imaxeon Pty, Ltd..

What is the FDA product code for MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)?

The FDA product code for MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) is IZQ.

Related Clinical Trials

Related PubMed Literature

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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.