# K083429: I.V. Catheter, Models: Type I, Type Y, Type Straight

- Pathway: 510(k) (Traditional)
- Applicant: Weihai Jierui Medical Products Co., Ltd.
- Decided: Aug 7, 2009 after 261 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: 2 generations back to K891087 (1989). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991406: Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter, Terumo Medical Corp. (1999) Summary page 2.

## Most influential descendants
- K142797: I.V. Catheter (2015), 0 descendants of its own

## Indications for use
I.V. Catheter for Single Use, including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors.

Source page: https://510kreport.com/device/K083429
Methodology: https://510kreport.com/methodology