# K992816: Modification to Intrastent

- Pathway: 510(k) (Special)
- Applicant: Intratherapeutics, Inc.
- Decided: Oct 15, 1999 after 56 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K911292 (1991). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980290: Iti Stent, Intratherapeutics, Inc. (1998) Summary page 1.
- K991929: Intrastent, Intratherapeutics, Inc. (1999) Summary page 1.
- K905720: Palmaz Biliary Stent, Johnson & Johnson Interventional Systems (1991) Summary page 1.
- K911581: Palmaz (TM) Balloon-Expandable Stent, Modification, Johnson & Johnson Interventional Systems (1991) Summary page 1.
- K964688: Long Medium Palmaz-Schatz Balloon Expandable Stent, Cordis Corp. (1997) Summary page 1.
- K980653: Perflex Stainless Steel Stent and Delivery System, Cordis Corp. (1998) Summary page 1.

## Indications for use
The IntraStent™ Biliary Stent is indicated as a palliative treatment for malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K992816
Methodology: https://510kreport.com/methodology