# K180416: ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Systems, Inc.
- Decided: Apr 17, 2018 after 61 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: 13 generations back to K871011 (1987). 23 ancestors in all.
No later device cites it as a predicate yet.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151260: ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD, Cardiovascular System, Inc. (2015) Summary page 4.
- K170792: Diamondback 360 Peripheral Orbital Atherectomy System, Cardiovascular Systems, Inc. (2017) Summary page 4.

## 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/K180416
Methodology: https://510kreport.com/methodology