# K983498: Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter Referred to as Bard Lubricious Ureteral Ste

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 15, 1998 after 71 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- 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 K903345 (1991). 1 ancestor in all.
16 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903345: Bard (R) Lubricious - Coated Ureteral Stent Suture, C.R. Bard, Inc. (1991) Summary page 2.

## Most influential descendants
- K022447: Bard ER Ureteral Stent with Suture (2003), 14 descendants of its own
- K043193: Bard Inlayoptima Ureteral Stent with Suture (2004), 12 descendants of its own
- K151051: Universa Soft Ureteral Stents and Stent Sets (2016), 11 descendants of its own
- K161236: Universa Firm Ureteral Stents and Stent Sets (2017), 5 descendants of its own
- K190312: Dornier Ureteral Stent (2019), 3 descendants of its own

## Recalls of this device
- Oct 13, 2016 · Class II · Z-0406-2017: Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
- Oct 13, 2016 · Class II · Z-0404-2017: Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

## Indications for use
The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.

Source page: https://510kreport.com/device/K983498
Methodology: https://510kreport.com/methodology