# K090262: Percucath Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Percuvision, LLC
- Decided: May 28, 2009 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 K860484 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002868: Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter; Bard Lubri-Sil I.C. 3-Way Foley Catheter, C.R. Bard, Inc. (2000) Summary page 1.
- K860484: Curity & Kenguard Silicone Coated Foley Catheter, The Kendal Co. (1986) Summary page 1.

## Most influential descendants
- K110214: Directvision Catheter, Uncoated (2011), 0 descendants of its own

## Indications for use
The PercuCathTM Catheter is indicated for use in the drainage and/or collection and/or measurement of urine. It is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as the nephrostomy tract.

Source page: https://510kreport.com/device/K090262
Methodology: https://510kreport.com/methodology