# K153682: Chocolate XD PTCA Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Trireme Medical, LLC
- Decided: Jun 23, 2016 after 184 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to P860019 (1986). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133633: Chocolate Ptca Bolloon Catheter, Trireme Medical, Inc. (2014) Summary page 4.
- K150292: Chocolate PTCA Balloon Catheter, Trireme Medical, LLC (2015) Summary page 4.

## Most influential descendants
- K233729: Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 (2024), 0 descendants of its own

## Indications for use
The Chocolate™ XD PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.

Source page: https://510kreport.com/device/K153682
Methodology: https://510kreport.com/methodology