# K072800: Diamondback 360 Degree Orbital Atherectomy System

- Pathway: 510(k) (Special)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Oct 25, 2007 after 24 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
Longest line of descent: 4 generations back to K871011 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071350: Diamondback 360 Degree Orbital Atherectomy System, Cardiovascular Systems, Inc. (2007) Summary page 1.
- K071427: Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt Stenosis, Cardiovascular Systems, Inc. (2007) Summary page 1.

## Indications for use
The Diamondback 360° TM 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° TM Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V grafts).

Source page: https://510kreport.com/device/K072800
Methodology: https://510kreport.com/methodology