# K251097: V-DAC Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vesalio, Inc.
- Decided: Jan 6, 2026 after 271 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- 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: 8 generations back to K003880 (2001). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183463: AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm, Stryker (2019) Summary page 5.

## Indications for use
The V-DAC Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral and neurovascular systems.

Source page: https://510kreport.com/device/K251097
Methodology: https://510kreport.com/methodology