# K962178: Bard Tiger Guidewire Model 000540

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 29, 1996 after 145 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 K931650 (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)
- K931650: Microvasive Insurg Geenen CBD Guide Wire, Boston Scientific Corp (1993) Summary page 2.
- K923755: Flex Finder Guidewire, Flex Medics Corporation (1993) Summary page 2.

## Indications for use
The Bard® Tiger™ guidewire is indicated for use with devices having a .035" guidewire compatible lumen. The Tiger guidewire is designed to guide and exchange endoscopic accessories into the G.l. Tract, including, but not limited to, the common bile, cystic, the right, and left hepatic and pancreatic ducts. It is not necessary to withdraw or remove the Tiger guidewire during sphincterotomy.

Source page: https://510kreport.com/device/K962178
Methodology: https://510kreport.com/methodology