# K993904: Intrastent Doublestrut LD

- Pathway: 510(k) (Traditional)
- Applicant: Intratherapeutics, Inc.
- Decided: Feb 1, 2000 after 76 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Most influential descendants
- K020528: Intrastent LD (Large Diameter) Stent (2002), 0 descendants of its own

## Recalls of this device
- Dec 29, 2005 · Not classified · Z-0829-06: IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001)

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

Source page: https://510kreport.com/device/K993904
Methodology: https://510kreport.com/methodology