# K133633: Chocolate Ptca Bolloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Trireme Medical, Inc.
- Decided: Jun 2, 2014 after 188 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: 4 generations back to P860019 (1986). 5 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K111544: Glider Ptca Balloon Catheter, Trireme Medical, Inc. (2012)
- K121681: Glider Ptca Balloon Catheter, Trireme Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- K150292: Chocolate PTCA Balloon Catheter (2015), 2 descendants of its own
- K153682: Chocolate XD PTCA Balloon Catheter (2016), 1 descendant of its own
- 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 ChocolateTm PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass gmaft stenosis for the purpose of improving myocardial perfusion.

Source page: https://510kreport.com/device/K133633
Methodology: https://510kreport.com/methodology