# K192399: Infinity Angioplasty Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Infinity Angioplasty Balloon Company, LLC
- Decided: May 20, 2020 after 260 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). 6 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K141112: Sterling Over-the Wire Pta Balloon Dilatation Catheter, Boston Scientific (2014) Summary page 4.

## Most influential descendants
- K214038: Oscar Peripheral Multifunctional Catheter system (2022), 2 descendants of its own
- K241711: Oscar Peripheral Multifunctional Catheter system (2024), 1 descendant of its own
- K250706: Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (2025), 0 descendants of its own

## Indications for use
The INFINITY Angioplasty Balloon Catheter™ is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary or cerebrovascular arteries.

Source page: https://510kreport.com/device/K192399
Methodology: https://510kreport.com/methodology