# K992668: Innerdyne Radially Expanding Vascular Access System (Revas)

- Pathway: 510(k) (Traditional)
- Applicant: Innerdyne, Inc.
- Decided: May 26, 2000 after 291 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 its predicate without a number.
- (no number) InnerDyne, Inc., REVAS products: named in the summary without a submission number

## Indications for use
The InnerDyne, Inc., REVAS product is intended to provide percutaneous access to the vasculature. The REVAS product is indicated for the following use: Percutaneous vascular access.

Source page: https://510kreport.com/device/K992668
Methodology: https://510kreport.com/methodology