# K133999: Diamondback 360 Peripheral Orbital Atherectomy System

- Pathway: 510(k) (Special)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Feb 28, 2014 after 63 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: 11 generations back to K871011 (1987). 19 ancestors in all.
No later device cites it as a predicate yet.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110389: Stealth 360 Orbital Pad System, Cardiovascular Systems, Inc. (2011)
- K122987: Stealth 360 Orbital Pad System, Cardiovascular Systems, Inc. (2012) Summary page 1.
- K131092: Stealth 360 Orbital Pad System, Cardio Systems, Inc. (2013) Summary page 2.
- K133399: Diamondback 360 Peripheral Orbital Atherectomy System, Cardiovascular Systems Incorporated (2013) Summary page 1.

## Indications for use
The Diamondback 360 Peripheral 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 OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

Source page: https://510kreport.com/device/K133999
Methodology: https://510kreport.com/methodology