# K141335: Expel Apd Drainage Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 17, 2014 after 149 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- K944290: Catheters, Biliary Catheters, Urological, Boston Scientific Corp (1994) Summary page 6.
- K023870: Flexima Biliary Catheter, Boston Scientific/Medi-Tech (2002) Summary page 6.

## Most influential descendants
- K181669: ConvertX Biliary Stent System (2019), 0 descendants of its own

## Recalls of this device
- Feb 25, 2015 · Class II · Z-1336-2015: Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmentation after
- Feb 25, 2015 · Class II · Z-1355-2015: Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimall

## Indications for use
The drainage catheter is intended to provide percutaneous drainage of abscess fluid and biliary collections. The drainage catheter is intended to provide external and internal percutaneous drainage of the biliary system.

Source page: https://510kreport.com/device/K141335
Methodology: https://510kreport.com/methodology