# K964780: Bard Director Guidewire (000560)

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Feb 26, 1997 after 91 days
- Product code: OCY (Endoscopic Guidewire, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K910497 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942677: Geenen/Zebra Guidelines, Boston Scientific Corp (1994) Summary page 2.
- K910497: Wilson Cook Wire Guide and Protective Guide, Wilson-Cook Medical, Inc. (1991) Summary page 2.
- K941334: Davol Laparoscopic Suction Irrigation Probe, Davol, Inc. (1994) Summary page 2.

## Indications for use
For use with devices having a .035" guidewire compatible lumen. The Director guidewire is used to guide endoscopic accessories into the GI tract and for cannulation of the pancreatobiliary ducts.

Source page: https://510kreport.com/device/K964780
Methodology: https://510kreport.com/methodology