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CATHTONG II PICC Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232571

by L & Z Us, Inc.

Identifiers

510(k) Number
K232571 FDA 510(k)
FDA Product Code
LJS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5970 FDA 510(k)
Regulation Number
880.5970 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CATHTONG II PICC Catheter is a peripherally inserted central catheter intended for short or long-term access to the central venous system. It is used for infusion, intravenous therapy, blood sampling, power injection of contrast media, administration of fluids and nutrients, and allows for central venous pressure monitoring.

This device is supplied as a single-use catheter and is classified as a Class II medical device. It is regulated under product code LJS with FDA 510(k) clearance number K232571, received on August 24, 2023, and granted on September 22, 2023. The device is intended for use in general hospital settings.

Frequently asked questions

What is the CATHTONG II PICC Catheter used for?

The CATHTONG II PICC Catheter is a peripherally inserted central catheter designed for short or long-term access to the central venous system. It is used for infusion, intravenous therapy, blood sampling, power injection of contrast media, administration of fluids and nutrients, and allows for central venous pressure monitoring in general hospital settings.

Is the CATHTONG II PICC Catheter single-use or reusable?

The CATHTONG II PICC Catheter is supplied as a single-use catheter and is classified as a Class II medical device. It is not intended to be reused due to infection risks and performance degradation after initial use.

What regulatory information is available for the CATHTONG II PICC Catheter?

The CATHTONG II PICC Catheter is regulated under product code LJS with FDA 510(k) clearance number K232571. It received FDA clearance on September 22, 2023, after being submitted on August 24, 2023. The device is intended for use in general hospital settings.

What are the specifications of the CATHTONG II PICC Catheter?

The CATHTONG II PICC Catheter is a Class II medical device with product code LJS. It is classified as substantially equivalent and is intended for general hospital use. The device is designed for both short and long-term central venous access, supporting various medical procedures including infusion, blood sampling, and contrast media injection.

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: CATHTONG II | L&Z US | Biomedical, CATHTONG? II PICC Catheter 510 (k) K232594 - FDA.report, CATHTONG™ II PICC Catheter (K232594) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
L & Z Us, Inc.
FDA Applicant
L&Z Us, Inc.

Sources (1)

  • FDA 510(k) K232571 24 fields · synced Sep 24, 2026