# K133399: Diamondback 360 Peripheral Orbital Atherectomy System

- Pathway: 510(k) (Special)
- Applicant: Cardiovascular Systems Incorporated
- Decided: Nov 22, 2013 after 16 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K871011 (1987). 18 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 23 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 1.
- 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 1.

## Most influential descendants
- K150732: Diamondback 360 Peripheral Orbital Atherectomy System (2015), 2 descendants of its own
- 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
- K133999: Diamondback 360 Peripheral Orbital Atherectomy System (2014), 0 descendants of its own

## Recalls of this device
- May 23, 2014 · Class I · Z-2155-2014: CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during us

## 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/K133399
Methodology: https://510kreport.com/methodology