# K142797: I.V. Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Sanxin Medtec Co., Ltd.
- Decided: Jun 18, 2015 after 262 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K891087 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083429: I.V. Catheter, Models: Type I, Type Y, Type Straight, Weihai Jierui Medical Products Co., Ltd. (2009) Summary page 5.

## Indications for use
The proposed device, I. V. Catheter, is intended to be inserted in to a patient's vascular system for short term use (no more than 72 hours) to withdraw blood samples or administer fluid intravenously.

Source page: https://510kreport.com/device/K142797
Methodology: https://510kreport.com/methodology