# K243432: Vascular Navigation PAD 2.0; Navigation Software Vascular PAD

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jul 22, 2025 after 259 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913770 (1991). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222070: EndoNaut, Therenva Sas (2022) Summary page 5.

## Indications for use
The software supports image guidance by overlaying vessel anatomy onto live fluoroscopic images in order to navigate guidewires, catheters, stents and other endovascular devices. The device is indicated for use by physicians for patients undergoing endovascular PAD interventions of the lower limbs including iliac vessels. The device is intended to be used in adults. There is no other demographic, ethnic or cultural limitation for patients. The information provided by the software or system is in no way intended to substitute for, in whole or in part, the physician’s judgment and analysis of the patient's condition.

Source page: https://510kreport.com/device/K243432
Methodology: https://510kreport.com/methodology