# K980282: Uresil Dilator with Radiopaque Marker

- Pathway: 510(k) (Traditional)
- Applicant: Uresil Corp.
- Decided: Apr 24, 1998 after 88 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is intended to help create a tract for catheter insertion.

Source page: https://510kreport.com/device/K980282
Methodology: https://510kreport.com/methodology