# K830840: Open Ended Ureteral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Van-Tec, Inc.
- Decided: Apr 6, 1983 after 21 days
- Product code: GBM (Catheter, Urethral)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 4 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Mar 17, 2003 · Not classified · Z-0734-03: Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
- Mar 17, 2003 · Not classified · Z-0740-03: Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
- Mar 17, 2003 · Not classified · Z-0735-03: Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
- Mar 17, 2003 · Not classified · Z-0736-03: Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use

Source page: https://510kreport.com/device/K830840
Methodology: https://510kreport.com/methodology