# K071427: Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt Stenosis

- Pathway: 510(k) (Special)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Aug 30, 2007 after 99 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: 2 generations back to K901206 (1990). 4 ancestors in all.
28 later devices descend from it; 3 cite it directly.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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

## Recalls of this device
- 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
- Mar 16, 2009 · Not classified · Z-1250-2009: CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month sh

## Indications for use
The Orbital Atherectomy System supports removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V Shunts).

Source page: https://510kreport.com/device/K071427
Methodology: https://510kreport.com/methodology