# K043243: Primus Stent and Delivery System

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Dec 9, 2004 after 16 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 3 (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. The FDA summary names its predicate without a number.
- (no number) previously cleared stent and delivery system: named in the summary without a submission number

## Recalls of this device
- Apr 22, 2008 · Not classified · Z-2170-2008: A Primus GPS Biliary Stent System was mislabeled. The mislabeling resulted in a 8 mm diameter, 27 mm length stent being labeled as a 8 mm x 37 mm stent.
- Mar 8, 2006 · Not classified · Z-0912-06: A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.
- Aug 1, 2005 · Not classified · Z-0442-06: A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.

## Indications for use
The ev3 PRIMUS TM Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K043243
Methodology: https://510kreport.com/methodology