Diamondback 360 Peripheral Orbital Atherectomy System— 510(k) K152694

Clearance details

Applicant

Cardiovascular Systems, Inc.

Product code

Code MCW

Device class

Class 2

Regulation

21 CFR 870.4875

Advisory panel

Cardiovascular

Date received

2015-09-21

Decision date

2015-10-21

Decision

Substantially Equivalent

Clearance type

Special

Location

St.Paul, MN, US

• K260244 — Auryon Atherectomy System2026-04-10
• K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)2025-04-25
• K250385 — Turbo-Elite Laser Atherectomy Catheter2025-03-13
• K242757 — Rotarex Atherectomy System2025-01-30
• K242947 — FreedomFlow Orbital Circumferential Atherectomy System2024-11-05

• K220109 — DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System2022-03-01
• K212725 — ViperCross Support Catheters2021-09-24
• K210586 — Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system2021-09-14
• K211240 — ViperCross Support Catheters2021-08-26
• K211251 — ViperCath XC Peripheral Exchange Catheter2021-05-26

Death

38

Injury

1,386

Malfunction

2,676

Other

2

Total

4,102

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0505-2018 — Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.Class II·Terminated·Cardiovascular Systems Inc·20170914
• Z-0506-2018 — Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.Class II·Terminated·Cardiovascular Systems Inc·20170914
• Z-1230-2017 — DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs The DIAMONDBACK 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system 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 system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. The Stealth 360 Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.Class II·Terminated·Cardiovascular Systems Inc·20161207

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152694.