# K172567: GORE Molding and Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore and Associates, Inc.
- Decided: Jan 31, 2018 after 159 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003495 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120381: Q50 Plus Stent Graft Balloon Catheter, Qxmedical, LLC (2012) Summary page 4.

## Recalls of this device
- Jul 12, 2021 · Class II · Z-2340-2021: Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.

## Indications for use
The GORE Molding and Occlusion Balloon Catheter is intended for temporary occlusion of large vessels or to assist in the expansion of self-expanding endovascular prostheses (stent grafts).

Source page: https://510kreport.com/device/K172567
Methodology: https://510kreport.com/methodology