# K980002: Koala Vascular Clamps and Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Boss Instruments, Ltd.
- Decided: Jun 18, 1998 after 167 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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 K951413 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951413: Fogarty-Hydragrip Surgical Clamps, Baxter Healthcare Corp (1995) Summary page 1.

## Indications for use
The Koala Vascular Clamps and Inserts are reusable, ring-handled stainless steel clamps for clamping delicate vessels during surgery. They are radiopaque, visualized under fluoroscopy.- Designed for tip-first closure to prevent vessel roll-out. Applications include - puimonary, gastrointestinal procedures, peripheral clamping, thoracic procedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.

Source page: https://510kreport.com/device/K980002
Methodology: https://510kreport.com/methodology