ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD— 510(k) K151260
Substantially EquivalentCardiovascular System, Inc.
FDA 510(k) clearance K151260 for ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD, Substantially Equivalent on 2015-06-10. Applicant: Cardiovascular System, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular System, Inc.
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Saint Paul, MN, US
Recent devices under product code MCW
view allAdverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K151260
K-number listed on FDA's recall record- Z-1771-2017 — ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. The guide wire torquer is a small, plastic accessory, packaged with the guide wire, and provides a gripping surface for manipulating the guide wire, if desired.
- Z-1877-2017 — ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151260.
Data sourced from openFDA. This site is unofficial and independent of the FDA.