# K973008: Courier ST Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 15, 1997 after 124 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.
6 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)
- None. The FDA summary names its predicate without a number.
- (no number) BSC -- PEMT-S Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) BSC -- Courier™ Balloon Catheter: named in the summary without a submission number

## Most influential descendants
- K011909: Ultra-Thin SDS Balloon Dilatation Catheter (2001), 5 descendants of its own
- 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

## Indications for use
The Marshal Balloon Dilatation Catheter is indicated for deployment of the PalmazTand the Palmaz-Schatz Balloon-Expanded Stents for the Biliary System. Marshal Catheters are not indicated for use in coronary artcries or the mneurovasculature.

Source page: https://510kreport.com/device/K973008
Methodology: https://510kreport.com/methodology