# K081944: Modification to Diamondback 360 Degree Orbital Atherectomy System

- Pathway: 510(k) (Special)
- Applicant: Cardio Systems, Inc.
- Decided: Aug 14, 2008 after 37 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: 5 generations back to K871011 (1987). 13 ancestors in all.
25 later devices descend from it; 1 cites 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.

## Most influential descendants
- K090521: Diamondback 360 DBX (2009), 24 descendants of its own
- 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

## 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 Diamondback 3600TM Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).

Source page: https://510kreport.com/device/K081944
Methodology: https://510kreport.com/methodology