# K063733: Resolve Biliary Drainage Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Nov 14, 2007 after 331 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981344 (1998). 1 ancestor in all.
2 later devices descend 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)
- K981344: Uresil Percutaneous Drainage Catheters with Hydrophilic Coating, Uresil Corp. (1998) Summary page 1.

## Most influential descendants
- K121832: Resolve Biliary Locking Drainage Catheter (2012), 1 descendant of its own
- K141408: Resolve Biliary Locking Drainage Catheter (2014), 0 descendants of its own

## Recalls of this device
- Nov 7, 2008 · Not classified · Z-0611-2009: Biliary drainage catheter tips may separate from the catheter shaft after placement.
- Nov 7, 2008 · Not classified · Z-0613-2009: Biliary drainage catheter tips may separate from the catheter shaft after placement.
- Nov 7, 2008 · Not classified · Z-0614-2009: Biliary drainage catheter tips may separate from the catheter shaft after placement.
- Nov 7, 2008 · Not classified · Z-0612-2009: Biliary drainage catheter tips may separate from the catheter shaft after placement.

## 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/K063733
Methodology: https://510kreport.com/methodology