# K151260: ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD

- Pathway: 510(k) (Special)
- Applicant: Cardiovascular System, Inc.
- Decided: Jun 10, 2015 after 29 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: 12 generations back to K871011 (1987). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110389: Stealth 360 Orbital Pad System, Cardiovascular Systems, Inc. (2011) Summary page 4.
- K122987: Stealth 360 Orbital Pad System, Cardiovascular Systems, Inc. (2012) Summary page 4.
- K131092: Stealth 360 Orbital Pad System, Cardio Systems, Inc. (2013) Summary page 4.
- K133399: Diamondback 360 Peripheral Orbital Atherectomy System, Cardiovascular Systems Incorporated (2013) Summary page 4.
- K150732: Diamondback 360 Peripheral Orbital Atherectomy System, Cardiovascular Systems, Inc. (2015) Summary page 4.

## Most influential descendants
- K180416: ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System (2018), 0 descendants of its own

## Recalls of this device
- Mar 3, 2017 · Class II · Z-1771-2017: Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because it may contain a 0.014" ViperWire Advance Flextip product instead of the 0.018" ViperWire
- Feb 9, 2017 · Class II · Z-1877-2017: CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018in ViperWire Advance with Flextip product was packaged as a 0.014in Viper

## Indications for use
The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems 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/K151260
Methodology: https://510kreport.com/methodology