# K991027: BI-Directional Tunneler

- Pathway: 510(k) (Special)
- Applicant: Impra, Inc.
- Decided: Apr 22, 1999 after 24 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- 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) Kelly-Wick Tunneler: named in the summary without a submission number

## Indications for use
The Bi-Driectional Tunneler is indicated for use in creating subcutaneous tunnels for the placement of vascular prostheses or autologous grafts for arteriovenous access, peripheral vascular and extra—anatomic bypass procedures.

Source page: https://510kreport.com/device/K991027
Methodology: https://510kreport.com/methodology