# K130484: Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Aug 9, 2013 after 165 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910931 (1991). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910931: Biliary Balloon Dilatation Catheter, Boston Scientific Corp (1991) Summary page 2.
- K001338: Microvasive Rapid Exchange Biliary Balloon Dilatation Catheter, Boston Scientific Corp (2000) Summary page 2.

## Most influential descendants
- K172520: CRE RX Biliary Balloon Dilatation Catheter (2017), 1 descendant of its own
- K241888: Single-use Balloon Dilatation Catheter (2024), 0 descendants of its own

## Recalls of this device
- Oct 21, 2021 · Class II · Z-0320-2022: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- Oct 21, 2021 · Class II · Z-0322-2022: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- Oct 21, 2021 · Class II · Z-0325-2022: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- Oct 21, 2021 · Class II · Z-0321-2022: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- Oct 21, 2021 · Class II · Z-0323-2022: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- Oct 21, 2021 · Class II · Z-0324-2022: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- Oct 21, 2021 · Class II · Z-0327-2022: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- Oct 21, 2021 · Class II · Z-0326-2022: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- Sep 16, 2020 · Class II · Z-0286-2021: RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.

## Indications for use
MaxForce Biliary Dilatation Catheter: The MaxForce Biliary Balloon Dilatation Catheters are recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. Hurricane RX Biliary Balloon Dilatation Catheter: The Hurricane RX Biliary Balloon Dilatation Catheter is recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. The Hurricane RX Biliary Balloon Dilatation Catheter may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.

Source page: https://510kreport.com/device/K130484
Methodology: https://510kreport.com/methodology