# K111315: Multipurpose Drainage Catheter

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Jun 8, 2011 after 29 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: 3 generations back to K944290 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
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.
- K103353: Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary Drainage Catheter, Navilyst Medical, Inc. (2011) Summary page 1.

## 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.

Source page: https://510kreport.com/device/K111315
Methodology: https://510kreport.com/methodology