# K090521: Diamondback 360 DBX

- Pathway: 510(k) (Special)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Mar 20, 2009 after 22 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K871011 (1987). 14 ancestors in all.
24 later devices descend from it; 3 cite it directly.
1 of 39 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072748: Modification to: Diamondback 360 Orbital Atherectomy System, Cardiovascular Systems, Inc. (2007) Summary page 1.
- K071350: Diamondback 360 Degree Orbital Atherectomy System, Cardiovascular Systems, Inc. (2007) Summary page 1.
- K081944: Modification to Diamondback 360 Degree Orbital Atherectomy System, Cardio Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K110389: Stealth 360 Orbital Pad System (2011), 20 descendants of its own
- K152694: Diamondback 360 Peripheral Orbital Atherectomy System (2015), 8 descendants of its own
- K122987: Stealth 360 Orbital Pad System (2012), 6 descendants of its own
- K131092: Stealth 360 Orbital Pad System (2013), 5 descendants of its own
- K190634: Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System (2019), 4 descendants of its own

## Recalls of this device
- Jun 13, 2016 · Class II · Z-2051-2016: The pouch label was missing the use by date (UBD) of 2018-04.
- Apr 16, 2009 · Not classified · Z-2028-2009: CSI is correcting (8) packages of Diamondback 360 due to a missing "Use By Date" on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for s

## 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 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/K090521
Methodology: https://510kreport.com/methodology