# K860267: Mardis Dangler Ureteral Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Van-Tec, Inc.
- Decided: Apr 3, 1986 after 66 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K960148: Circon-Surgitek Classic Double Pigtail Ureteral Stent (1996), 0 descendants of its own

## Recalls of this device
- Mar 18, 2009 · Not classified · Z-1342-2009: Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, suture

Source page: https://510kreport.com/device/K860267
Methodology: https://510kreport.com/methodology