# K181323: Atlas Gold PTA Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 3, 2018 after 77 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 K933483 (1993). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122984: Atlas Gold Pta Dilatation Catheter, C.R. Bard, Inc. (2012) Summary page 6.

## Most influential descendants
- K212588: Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter (2022), 2 descendants of its own
- K241040: Amethyst HP PTA OTW 0.035 Catheter (2024), 1 descendant of its own
- K254212: NC PTA Balloon Dilatation Catheter (2026), 0 descendants of its own
- K251915: Amethyst HP PTA OTW 0.035 Catheter (2025), 0 descendants of its own

## Indications for use
The Atlas® Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K181323
Methodology: https://510kreport.com/methodology