# K033134: Modification to Paramount Mini Stent and Delivery System

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Nov 17, 2003 after 48 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 36 (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 no predicate by number.

## Recalls of this device
- Jan 29, 2004 · Not classified · Z-0604-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0605-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0611-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0613-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0614-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0618-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0620-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0624-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0627-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0599-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0602-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0609-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0612-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0616-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0617-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0621-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0623-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0628-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0629-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0631-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0597-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0598-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0600-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0601-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0603-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0608-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0610-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0622-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0625-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0626-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0630-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0632-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0606-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0607-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0615-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
- Jan 29, 2004 · Not classified · Z-0619-04: After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.

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

Source page: https://510kreport.com/device/K033134
Methodology: https://510kreport.com/methodology