# K182914: MC3 Vascular Access Kit 21030

- Pathway: 510(k) (Traditional)
- Applicant: Mc3 Incorporated
- Decided: Oct 29, 2018 after 11 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- 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 K891022 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081940: Avalon Elite Vascular Access Kit, Avalon Laboratories, LLC (2008) Summary page 4.

## Indications for use
Intended for single use by a trained physician to assist in vessel cannulation.

Source page: https://510kreport.com/device/K182914
Methodology: https://510kreport.com/methodology