# K103371: Coude/ or Tiemann

- Pathway: 510(k) (Traditional)
- Applicant: Degania Silicone, Ltd.
- Decided: Mar 11, 2011 after 114 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- 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 K063442 (2007). 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)
- K063442: All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature Sensor, Degania Silicone, Ltd. (2007) Summary page 3.

## Indications for use
Coude Foley catheter / or Tiemann Foley Catheter! is all silicone Foley catheter 2-way intended for urological use only. Indicated for routine drainage of the urinary bladder. Maximum recommended indwelling time is not more than 30 days.

Source page: https://510kreport.com/device/K103371
Methodology: https://510kreport.com/methodology