# K111334: Benelli Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Aug 1, 2011 after 81 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: 2 generations back to K810675 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
3 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021120: Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP, Arrow Intl., Inc. (2002) Summary page 1.
- K032843: Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2004) Summary page 1.

## Indications for use
The Benelli is intended for use in accessing the peripheral vasculature.

Source page: https://510kreport.com/device/K111334
Methodology: https://510kreport.com/methodology