Identifiers
- 510(k) Number
- K172039 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 percutaneously implanted, long-term intravascular catheter intended for peripheral access to the central venous system. It is designed for infusion, intravenous therapy, blood sampling, power injection of contrast media, administration of fluids, medications and nutrients, and allows for central venous pressure monitoring.
This Class 2 device with product code LJS is manufactured by L&Z US, Inc. and is cleared through the Special 510(k) pathway. The device is supplied as a sterile, single-use product and is regulated under 21 CFR 880.5970 for percutaneous, implanted, long-term intravascular catheters.
Frequently asked questions
What is the Cathtong II PICC Catheter used for?
The Cathtong II PICC Catheter is intended for peripheral access to the central venous system to support infusion, intravenous therapy, blood sampling, power injection of contrast media, administration of fluids, medications and nutrients, and central venous pressure monitoring.
Is the Cathtong II PICC Catheter sterile and single-use?
Yes, the Cathtong II PICC Catheter is supplied as a sterile, single-use product, meaning it is intended for one patient and one procedure only to reduce infection risk and ensure safety.
What regulatory pathway was used for the Cathtong II PICC Catheter?
The Cathtong II PICC Catheter was cleared through the Special 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device under FDA regulations.
What is the product code and classification for the Cathtong II PICC Catheter?
The Cathtong II PICC Catheter has product code LJS and is classified as a Class 2 medical device, regulated under 21 CFR 880.5970 for percutaneous, implanted, long-term intravascular catheters.
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, K232594 FDA 510(k) - CATHTONG II PICC Catheter | L&Z Us, Inc., CATHTONG™ II PICC Catheter (K232594) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172039 | Class II | Active |
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Manufacturer
- Manufacturer
- L & Z Us, Inc.
- FDA Applicant
- L&Z Us, Inc.
Sources (1)
- FDA 510(k) K172039 24 fields · synced Sep 26, 2026