# K111544: Glider Ptca Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Trireme Medical, Inc.
- Decided: Mar 2, 2012 after 273 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: 2 generations back to P860019 (1986). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986) Summary page 1.
- K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter, Creganna-Tactx Medical (2011). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K121681: Glider Ptca Balloon Catheter (2012), 4 descendants of its own
- K133633: Chocolate Ptca Bolloon Catheter (2014), 3 descendants of its own
- 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 Glider PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Source page: https://510kreport.com/device/K111544
Methodology: https://510kreport.com/methodology