# K103353: Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary Drainage Catheter

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Jan 14, 2011 after 59 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944290 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093392: Multipurpose, Nephrostomy and Biliary Drainage Catheters, Navilyst Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K111315: Multipurpose Drainage Catheter (2011), 0 descendants of its own

## Indications for use
Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air from the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections. Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

Source page: https://510kreport.com/device/K103353
Methodology: https://510kreport.com/methodology