# K121402: Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon Catheter (Over the Wire) 0.018' G

- Pathway: 510(k) (Special)
- Applicant: Trireme Medical, Inc.
- Decided: Jun 8, 2012 after 29 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001134 (2000). 39 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090849: Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090, AB14W020210150, Ev3, Inc. (2009) Summary page 1.
- K082343: Vascutrak 2, Models: V14 and V18, Ymed, Inc. (2008) Summary page 1.
- K094019: Glider Pta Balloon Catheter, Trireme Medical, Inc. (2010) Summary page 1.
- K101062: Glider Pta Balloon Catheter, Trireme Medical, Inc. (2010) Summary page 1.
- K103534: Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide Wire, Trireme Medical, Inc. (2011) Summary page 1.
- K112281: Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXX, Trireme Medical, Inc. (2011) Summary page 1.
- K111738: Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018), Trireme Medical, Inc. (2011)
- K120677: Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014), Trireme Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- K122070: Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (Over the Wire) 0.18 G (2012), 2 descendants of its own
- K130414: Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (Over the Wire) 0.018 (2013), 1 descendant of its own
- K213631: Chocolate PTA Balloon Catheter (2021), 0 descendants of its own

## Indications for use
The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ijio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature. The indication for use is the same for all members of the Chocolate PTA Balloon Catheter Family.

Source page: https://510kreport.com/device/K121402
Methodology: https://510kreport.com/methodology