# K980290: Iti Stent

- Pathway: 510(k) (Traditional)
- Applicant: Intratherapeutics, Inc.
- Decided: Jul 21, 1998 after 176 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905720 (1991). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K991929: Intrastent (1999), 3 descendants of its own
- K993904: Intrastent Doublestrut LD (2000), 1 descendant of its own
- K020528: Intrastent LD (Large Diameter) Stent (2002), 0 descendants of its own
- K992816: Modification to Intrastent (1999), 0 descendants of its own

## Recalls of this device
- Jan 18, 2008 · Not classified · Z-1128-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Jan 18, 2008 · Not classified · Z-1123-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Jan 18, 2008 · Not classified · Z-1121-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Jan 18, 2008 · Not classified · Z-1129-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Jan 18, 2008 · Not classified · Z-1131-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Jan 18, 2008 · Not classified · Z-1124-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Jan 18, 2008 · Not classified · Z-1126-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Jan 18, 2008 · Not classified · Z-1122-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Jan 18, 2008 · Not classified · Z-1125-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Jan 18, 2008 · Not classified · Z-1120-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Jan 18, 2008 · Not classified · Z-1127-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
- Jan 18, 2008 · Not classified · Z-1130-2008: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.

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

Source page: https://510kreport.com/device/K980290
Methodology: https://510kreport.com/methodology