# K030630: Edwards Directional Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Sep 3, 2003 after 188 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931794 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012749: Biocardia Universal Deflectable Guide Catheter, Model 000664, Biocardia, Inc. (2002)
- K974683: Naviport Deflectable Tip Guiding Catheter, Cardima, Inc. (1999) Summary page 1.

## Indications for use
The Edwards Directional Catheter is indicated to facilitate the placement of guidewires in bifurcations or any sidebranch vasculature.

Source page: https://510kreport.com/device/K030630
Methodology: https://510kreport.com/methodology