# K153469: Cathtong I PICC Catheter

- Pathway: 510(k) (Special)
- Applicant: L&Z Us, Inc.
- Decided: Sep 1, 2016 after 275 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
Longest line of descent: 14 generations back to K001901 (2000). 47 ancestors in all.
No later device cites it as a predicate yet.
2 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140266: Nmi Picc IV, Navilyst Medical, Inc. (2014) Summary page 4.

## Indications for use
The CATHTONG™ I 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 ImL/sec for 3F and 3.5mL/sec for 4F single-lumen catheters. The maximum pressure of power injection with the CATHTONG™ I PICC Catheter may not exceed 325 psi. The CATHTONG™ I PICC Catheter is indicated for adult patients. Catheter Size Maximum Flow Rate Injection Limit Setting 3 Fr Single Lumen 1 ml/sec 325 psi 4 Fr Single Lumen 3.5 ml/sec 325 psi

Source page: https://510kreport.com/device/K153469
Methodology: https://510kreport.com/methodology