# K011909: Ultra-Thin SDS Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 28, 2001 after 162 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: 1 generation back to K973008 (1997). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973008: Courier ST Balloon Dilatation Catheter, Boston Scientific Corp (1997) Summary page 1.

## Most influential descendants
- K021630: Boston Scientific Express Biliary LD Premounted Stent System (2002), 4 descendants of its own
- K024048: Modification to Boston Scientific Express Biliary LD Premounted Stent System (2003), 3 descendants of its own
- K030645: Boston Scientific Express Biliary LD Unmounted Stent (2003), 2 descendants of its own
- K032360: Modification to Boston Scientific Express Biliary LD Premounted Stent System and Express Biliary LD Unmounted Stent (2003), 1 descendant of its own
- K133110: Express LD Biliary Premounted Stent System (2014), 0 descendants of its own

## Indications for use
Ultra-Thin SDS Balloon Dilatation Catheters are indicated for stent deployent/optimization of the Johnson & Johnson Palmaz® Biliary Stent and for the treatment of biliary strictures.

Source page: https://510kreport.com/device/K011909
Methodology: https://510kreport.com/methodology