# K091306: Amsure PVC Intermittent Catheter

- Pathway: 510(k) (Special)
- Applicant: Amsino International, Inc.
- Decided: Aug 21, 2009 after 109 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 K030712 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030712: Amsure Urethral Catheterization Tray, Amsino International, Inc. (2003) Summary page 1.

## Most influential descendants
- K181445: AMSure Hydrophilic Intermittent Catheter (2018), 0 descendants of its own

## Indications for use
The AMSure PVC Intermittent Catheter is intended for use in the drainage of urine from the bladder.

Source page: https://510kreport.com/device/K091306
Methodology: https://510kreport.com/methodology