# P210039: Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)

- Pathway: PMA
- Applicant: Trireme Medical, LLC
- Decided: Nov 4, 2022 after 312 days
- Product code: ONU (Drug-Eluting Peripheral Transluminal Angioplasty Catheter)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P210039
Methodology: https://510kreport.com/methodology