# K123264: DK-Ptca Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Intuit Medical, LLC
- Decided: Jan 16, 2013 after 90 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.
No later device cites it as a predicate yet.
0 of 5 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 4.
- K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter, Creganna-Tactx Medical (2011) Summary page 4.

## Indications for use
The Intuit Medical, LLC, DK-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/K123264
Methodology: https://510kreport.com/methodology