# K980578: Innerdyne Radially Expanding Vascular Access System (Heparin Coated)

- Pathway: 510(k) (Traditional)
- Applicant: Innerdyne, Inc.
- Decided: Sep 11, 1998 after 206 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
Longest line of descent: 2 generations back to K931489 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972684: Innerdyne Radially Expanding Vascular Access System, Innerdyne, Inc. (1997) Summary page 1.

## Indications for use
The InnerDyne, Inc., Radially Expanding Vascular Access System (Heparin Coated) is intended to provide percutaneous access to the vasculature. The Radially Expanding Vascular Access System (Heparin Coated) is indicated for the following usages: . Percutaneous vascular access.

Source page: https://510kreport.com/device/K980578
Methodology: https://510kreport.com/methodology