# K030538: American Catheter, Model W3

- Pathway: 510(k) (Traditional)
- Applicant: Catheter, LLC
- Decided: Mar 10, 2003 after 18 days
- Product code: EZD (Catheter, Straight)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863082 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863082: Cook-Vpi Intermittent Catheter, Cook Urological, Inc. (1986) Summary page 1.

## Indications for use
Used for female intermittent self-catheterization of the bladder. Curved design permits ease of placement. The grip area makes the catheter easier for patients to manipulate. Non-sterile Reusable. Intended for single patient use

Source page: https://510kreport.com/device/K030538
Methodology: https://510kreport.com/methodology