# K150732: Diamondback 360 Peripheral Orbital Atherectomy System

- Pathway: 510(k) (Special)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Apr 13, 2015 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: 11 generations back to K871011 (1987). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 22 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) Summary page 4.
- K122987: Stealth 360 Orbital Pad System, Cardiovascular Systems, Inc. (2012) Summary page 4.
- K131092: Stealth 360 Orbital Pad System, Cardio Systems, Inc. (2013) Summary page 4.
- K133399: Diamondback 360 Peripheral Orbital Atherectomy System, Cardiovascular Systems Incorporated (2013) Summary page 4.

## Most influential descendants
- K151260: ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD (2015), 1 descendant of its own
- K180416: ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System (2018), 0 descendants of its own

## 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/K150732
Methodology: https://510kreport.com/methodology