# K170486: CATHTONG II PICC Catheter

- Pathway: 510(k) (Special)
- Applicant: L&Z Us, Inc.
- Decided: May 25, 2017 after 101 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CATHTONG™ II PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 2.5 mL/sec for 4F and 5.0 mL/sec for 5F dual lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients. Catheter Size Maximum Flow Rate Injection Limit Setting 4 F Dual Lumen 2.5 mL/sec 325 psi 5 F Dual Lumen 5.0 mL/sec 325 psi

Source page: https://510kreport.com/device/K170486
Methodology: https://510kreport.com/methodology