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MAGIC Infusion Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K202366

by Balt Usa Llc

Identifiers

510(k) Number
K202366 FDA 510(k)
FDA Product Code
KRA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1210 FDA 510(k)
Regulation Number
870.1210 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MAGIC Infusion Catheter is a continuous flush catheter designed for selective infusion into neurovascular vessels. It facilitates controlled regional delivery of contrast materials or other therapeutic agents, enabling precise interventions in peripheral and neurovascular procedures.

This device is intended for single-use in clinical settings and is classified as a Class II medical device under FDA regulations. Available in multiple sizes and configurations, it is supplied sterile and must be handled according to aseptic techniques. The MAGIC Infusion Catheter holds FDA 510(k) clearance (K202366) and adheres to regulatory standards for neurovascular applications, ensuring compatibility with diagnostic and interventional procedures.

Frequently asked questions

What is the MAGIC Infusion Catheter used for?

The MAGIC Infusion Catheter is designed for selective infusion into neurovascular vessels, facilitating controlled regional delivery of contrast materials or other therapeutic agents during peripheral and neurovascular procedures.

Is the MAGIC Infusion Catheter intended for single-use or reuse?

The MAGIC Infusion Catheter is intended for single-use in clinical settings, as stated in its description, and must be discarded after one procedure to maintain sterility and safety.

How is the MAGIC Infusion Catheter supplied and what handling is required?

The device is supplied sterile and must be handled using aseptic techniques to maintain its sterility until point of use, as specified in the device description.

What regulatory pathway was used for the MAGIC Infusion Catheter?

The MAGIC Infusion Catheter received FDA 510(k) clearance under the traditional pathway, with clearance number K202366, as indicated in the AUTHORIZATIONS and device data fields.

What sizes and configurations are available for the MAGIC Infusion Catheter?

The MAGIC Infusion Catheter is available in multiple sizes and configurations, as noted in the DESCRIPTION, though specific dimensions or model numbers are not provided in the device data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Magic - Balt Group, Magic Infusion Catheter MAGICMP Magic Infusion… - FDA.report, BALT USA LLC MAGIC1.5F Magic Infusion Catheter, Magic Infusion Catheter MAGICMP Magic Infusion… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Balt Usa Llc
FDA Applicant
Balt USA, LLC

Sources (1)

  • FDA 510(k) K202366 24 fields · synced Sep 19, 2026