# K181979: Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: May 24, 2019 after 303 days
- Product code: KOD (Catheter, Urological)
- 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 K000070 (2000). 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)
- K000070: Flocath, Rusch Intl. (2000) Summary page 4.

## Indications for use
The subject device is a tubular device that is inserted through the urethra to pass urine from the bladder.

Source page: https://510kreport.com/device/K181979
Methodology: https://510kreport.com/methodology