# K103534: Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Trireme Medical, Inc.
- Decided: Jan 5, 2011 after 35 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 7 generations back to K001134 (2000). 18 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 25 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.
- K082579: Evercross .035 Otw Pta Dilatation Catheter, Ev3, Inc. (2008) Summary page 1.
- K101062: Glider Pta Balloon Catheter, Trireme Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K120677: Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014) (2012), 4 descendants of its own
- K112281: Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXX (2011), 4 descendants of its own
- K121402: Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon Catheter (Over the Wire) 0.018' G (2012), 3 descendants of its own
- 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

## Indications for use
The GLiderfleX TM PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, illo-femoral, popliteal, infra-politeal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K103534
Methodology: https://510kreport.com/methodology