# K071350: Diamondback 360 Degree Orbital Atherectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Aug 22, 2007 after 100 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: 3 generations back to K871011 (1987). 10 ancestors in all.
28 later devices descend from it; 6 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)
- K901206: Rotablator, Heart Technology, Inc. (1990) Summary page 1.
- K043553: Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300, Fox Hollow Technologies (2005) Summary page 1.
- K041630: Orbital Atherectomy System for Treatment of a-V Shunt Stenosis, Cardiovascular Systems Incorporated (2005) Summary page 1.

## Most influential descendants
- K072748: Modification to: Diamondback 360 Orbital Atherectomy System (2007), 26 descendants of its own
- K081944: Modification to Diamondback 360 Degree Orbital Atherectomy System (2008), 25 descendants of its own
- 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

## 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 are who are acceptable candidates for percutaneous transluminal atherectomy.

Source page: https://510kreport.com/device/K071350
Methodology: https://510kreport.com/methodology