# K972684: Innerdyne Radially Expanding Vascular Access System

- Pathway: 510(k) (Traditional)
- Applicant: Innerdyne, Inc.
- Decided: Oct 10, 1997 after 85 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: 1 generation back to K931489 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931489: Intherm Radially Expanding Dilating Introducer, Innerdyne Medical, Inc. (1993) Summary page 1.

## Most influential descendants
- K980578: Innerdyne Radially Expanding Vascular Access System (Heparin Coated) (1998), 0 descendants of its own

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

Source page: https://510kreport.com/device/K972684
Methodology: https://510kreport.com/methodology