# K911581: Palmaz (TM) Balloon-Expandable Stent, Modification

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Interventional Systems
- Decided: Jun 4, 1991 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
No predicates in its family tree.
36 later devices descend from it; 12 cite it directly.
0 of 37 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
- K990631: Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC (1999), 21 descendants of its own
- K991028: Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories (1999), 19 descendants of its own
- K992755: Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping Tools, Cordis Introducer Tube (1999), 17 descendants of its own
- K994156: Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B, PQ394B (2000), 11 descendants of its own
- K012056: Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System (2001), 9 descendants of its own

Source page: https://510kreport.com/device/K911581
Methodology: https://510kreport.com/methodology