# K260459: VANES Delivery System (VDS)

- Pathway: 510(k) (Traditional)
- Applicant: Zoll Respicardia, Inc.
- Decided: Apr 6, 2026 after 54 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000659 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152116: 5.5 F Worley Advanced LVI Lateral Vein Introducer, Merit Medical Systems, Inc. (2015) Summary page 5.

## Indications for use
For the introduction of various types of pacing or defibrillation leads and catheters.

Source page: https://510kreport.com/device/K260459
Methodology: https://510kreport.com/methodology