# K121681: Glider Ptca Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Trireme Medical, Inc.
- Decided: Jun 26, 2012 after 19 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: 3 generations back to P860019 (1986). 4 ancestors in all.
4 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) Summary page 2.
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986). The summary prints P860019, a PMA number, which our reading took as K860019. Corrected to the number the summary prints. Summary page 1.
- K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter, Creganna-Tactx Medical (2011)

## Most influential descendants
- 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 Dilatation 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/K121681
Methodology: https://510kreport.com/methodology