# K993303: Semi Compliant (SC) 35 Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 23, 2000 after 171 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) Ultra-thin Diamond Dilatation Catheter: named in the summary without a submission number
- (no number) Courier ST Balloon Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K110122: Mustang Balloon Dilataion Catheters (2011), 2 descendants of its own
- K141597: Mustang Balloon Dialation Catheter (2014), 0 descendants of its own
- K112701: Charger Balloon Dilatation Catheter (2011), 0 descendants of its own

## Indications for use
The Semi Compliant 35 Balloon Dilatation Catheter is indicated for stent deployment/optimization of the J&J Paimaz Biliary Stent and for the treatment of biliary strictures.

Source page: https://510kreport.com/device/K993303
Methodology: https://510kreport.com/methodology