# K140917: Introducer, Model Adelante Magnum

- Pathway: 510(k) (Traditional)
- Applicant: Oscor, Inc.
- Decided: Jul 9, 2014 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Adelantee Magnum is intended to facilitate the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements, while minimizing blood loss associated with such insertions. Do not use this device for neural placements.

Source page: https://510kreport.com/device/K140917
Methodology: https://510kreport.com/methodology