# K121832: Resolve Biliary Locking Drainage Catheter

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jul 17, 2012 after 25 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981344 (1998). 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)
- K063733: Resolve Biliary Drainage Catheter, Merit Medical Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- K141408: Resolve Biliary Locking Drainage Catheter (2014), 0 descendants of its own

## Recalls of this device
- Jan 16, 2013 · Class II · Z-0866-2013: A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.

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

Source page: https://510kreport.com/device/K121832
Methodology: https://510kreport.com/methodology