# K250219: Dorado™ PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Jun 17, 2025 after 144 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 5 generations back to K001134 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072283: Dorado Pta Balloon Dilatation Catheter, Bard Peripheral Vascular, Inc. (2007) Summary page 5.

## Indications for use
Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K250219
Methodology: https://510kreport.com/methodology