# K003040: Intrastent Protege Self-Expanding Nitinol Stent with Starport Delivery Technology

- Pathway: 510(k) (Traditional)
- Applicant: Intratherapeutics, Inc.
- Decided: Dec 28, 2000 after 90 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012066: Protege Self-Expanding Nitinol Stent with Starport Delivery Technology (2001), 2 descendants of its own
- K012347: Protege Self-Expanding Nitinol Stent with Starport Delivery Technology (2001), 1 descendant of its own
- K021729: Modification to Protege Self-Expanding Nitinol Stent with Starport Delivery Technology (2002), 0 descendants of its own
- K014136: Modification to Protege Self-Expanding Nitinol Stent with Starport Delivery Technology (2002), 0 descendants of its own
- K011806: Protege Self-Expanding Nitinol Stent with Starport Delivery Technology (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K003040
Methodology: https://510kreport.com/methodology