# K082981: Diamondback 360 Degree Orbital Atherectomy System with Viperslide Lubricant

- Pathway: 510(k) (Special)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Oct 31, 2008 after 25 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K111388: Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad System (2011), 0 descendants of its own

## Indications for use
The Diamondback 360°T™ Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The Diamondback 360°™ Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V shunts).

Source page: https://510kreport.com/device/K082981
Methodology: https://510kreport.com/methodology