# K171223: Quantum TTC Biliary Balloon Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jun 16, 2017 after 51 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935094 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935094: Balloon Dilation Catheter, Wilson-Cook Medical, Inc. (1995) Summary page 4.

## Recalls of this device
- Nov 3, 2023 · Class II · Z-0461-2024: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impact
- Nov 3, 2023 · Class II · Z-0463-2024: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impact
- Nov 3, 2023 · Class II · Z-0457-2024: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impact
- Nov 3, 2023 · Class II · Z-0459-2024: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impact
- Nov 3, 2023 · Class II · Z-0462-2024: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impact
- Nov 3, 2023 · Class II · Z-0460-2024: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impact
- Nov 3, 2023 · Class II · Z-0458-2024: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impact

## Indications for use
The Quantum TTC Biliary Balloon Dilator is used to dilate strictures of the biliary tree.

Source page: https://510kreport.com/device/K171223
Methodology: https://510kreport.com/methodology