# K101062: Glider Pta Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Trireme Medical, Inc.
- Decided: May 12, 2010 after 26 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: 6 generations back to K001134 (2000). 17 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 26 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.
- K080982: Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters, Boston Scientific Corp (2008) Summary page 1.
- K082579: Evercross .035 Otw Pta Dilatation Catheter, Ev3, Inc. (2008) Summary page 1.

## Most influential descendants
- K103534: Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide Wire (2011), 6 descendants of its own
- K111738: Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018) (2011), 5 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K101062
Methodology: https://510kreport.com/methodology