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Magic3 Go Intermittent Urinary Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K150345

by C. R. Bard, Inc.

Identifiers

510(k) Number
K150345 FDA 510(k)
FDA Product Code
EZD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5130 FDA 510(k)
Regulation Number
876.5130 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Magic3 Go Intermittent Urinary Catheter is a straight, single‑use catheter designed for intermittent drainage of the urinary bladder. It is classified as a Class II medical device and was cleared through a traditional FDA 510(k) submission (K150345) as substantially equivalent to a predicate device.

The catheter is intended for urological use in both adult and pediatric patients for bladder management, including urine drainage, collection, and measurement. It is supplied sterile, conforms to product code EZD, and is regulated under FDA 510(k) clearance with a decision date of 2015‑05‑11.

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: Magic3 Go™ Hydrophilic Catheters - BD, BARD MAGIC3 GO INSTRUCTIONS FOR USE MANUAL Pdf Download, Magic3 Go Intermittent Urinary Catheter Manual | AI Chat & PDF Download ..., BARD MAGIC3 GO QUICK START MANUAL Pdf Download | ManualsLib, Magic3 Go Intermittent Urinary Catheter (K172247) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K150345 24 fields · synced Sep 28, 2026