# K903345: Bard (R) Lubricious - Coated Ureteral Stent Suture

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 30, 1991 after 279 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983498: Bard Inlay Lubricious Double Pigtail Ureteral Stent with Suture (Hereinafter Referred to as Bard Lubricious Ureteral Ste (1998), 16 descendants of its own
- 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

Source page: https://510kreport.com/device/K903345
Methodology: https://510kreport.com/methodology