# K970494: Hannibal Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Schneider (Europe) GmbH
- Decided: May 9, 1997 after 88 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACS Hi-Torque Extra Sport™ Guidewire: named in the summary without a submission number
- (no number) C-Thru Coronary Guidewire: named in the summary without a submission number

## Indications for use
The HANNIBAL™ steerable guide wires are designed ta reach and cross stenotic lesions prior to the insertion on a coronary balloon dilatation catheter. Schneider steerable stent support guide wires are also designed to reach and cross stenotic lesions prior to the insartion of 2 caronary halloon dilatation catheter with mounted expandable stent, or of a stent dellvery device.

Source page: https://510kreport.com/device/K970494
Methodology: https://510kreport.com/methodology