# K062852: Balloon Expandable Transseptal Indroducer, Models Beti-1840 and Beti-1870

- Pathway: 510(k) (Traditional)
- Applicant: Onset Medical Corporation
- Decided: Feb 23, 2007 after 151 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 Onset Balloon Expandable Transseptal Introducer (BETI) is intended to establish a conduit, into the left side of the heart, through the inter-atrial septum, for the introduction of various cardiovascular catheters.

Source page: https://510kreport.com/device/K062852
Methodology: https://510kreport.com/methodology