# K141408: Resolve Biliary Locking Drainage Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Nov 26, 2014 after 182 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 K981344 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121832: Resolve Biliary Locking Drainage Catheter, Merit Medical Systems, Inc. (2012) Summary page 4.

## Indications for use
The ReSolve Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.

Source page: https://510kreport.com/device/K141408
Methodology: https://510kreport.com/methodology