# K111388: Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Jul 26, 2011 after 70 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: 8 generations back to K871011 (1987). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 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.
- K082981: Diamondback 360 Degree Orbital Atherectomy System with Viperslide Lubricant, Cardiovascular Systems, Inc. (2008) Summary page 1.
- K090521: Diamondback 360 DBX, Cardiovascular Systems, Inc. (2009) Summary page 1.
- K110389: Stealth 360 Orbital Pad System, Cardiovascular Systems, Inc. (2011) Summary page 1.

## Indications for use
The Diamondback 3600 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 GAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The GAS is a percutaneous orbital atherectomry system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous translumninal angioplasty.

Source page: https://510kreport.com/device/K111388
Methodology: https://510kreport.com/methodology