Magic Infusion Catheter

FDA UDI

Class II (US FDA UDI)

by Balt Usa Llc

Identity

Trade Name: Magic Infusion Catheter FDA UDI
Generic Name: Vascular microcatheter FDA UDI
Device Name: Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into selected vessels in the neurovasculature. Magic Infusion Catheters are intended to facilitate access through distant, tortuous vasculature. Progressive suppleness ranging from a highly flexible tip to a semi-rigid proximal section allows the catheter to be advanced by the physician. It is not intended for use in the coronary vasculature. FDA UDI
Model / Reference: MA1.5FMP FDA UDI
Description: Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into selected vessels in the neurovasculature. Magic Infusion Catheters are intended to facilitate access through distant, tortuous vasculature. Progressive suppleness ranging from a highly flexible tip to a semi-rigid proximal section allows the catheter to be advanced by the physician. It is not intended for use in the coronary vasculature. FDA UDI

Identifiers

Primary DI / UDI-DI: 00818053022623 FDA UDI
510(k) Number: K023351 FDA UDI
FDA Product Code: KRA FDA UDI
GMDN Term: Vascular microcatheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1210 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Catheter Length — 165 Centimeter FDA UDI
Catheter Inner Diameter — .29 Millimeter FDA UDI

Category: Vascular microcatheter

Magic Infusion Catheter by Balt Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular microcatheter.

Velocity Delivery Microcatheter — PENUMBRA, INC. · Class II
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Renegade™ HI-FLO™ Kit — Boston Scientific · Class II
PROWLER — Medos International Sàrl · Class II
Merit Maestro® — Merit Medical Systems, Inc. · Class II
Lantern Delivery Catheter — PENUMBRA, INC. · Class II
Direxion™ Fathom™-16 System — Boston Scientific · Class II

Cleared under the same submission

K023351 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Balt Usa Llc

Sources (1)

FDA UDI abd3bcd7-dc29-435f-9be0-bbaefe832b76 37 fields · synced Jun 8, 2026