DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM— 510(k) K133399

Name: FDA 510(k) clearance K133399
Creator: U.S. Food and Drug Administration
Published: 2013-11-22

Substantially Equivalent

Cardiovascular Systems Incorporated

FDA 510(k) clearance K133399 for DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, Substantially Equivalent on 2013-11-22. Applicant: Cardiovascular Systems Incorporated. Device class: 2.

Clearance details

Applicant: Cardiovascular Systems Incorporated
Product code: Code MCW
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 2013-11-06
Decision date: 2013-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint Paul, MN, US

Download summary PDF View on FDA.gov ↗

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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

More clearances from Cardiovascular Systems Incorporated

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K041630 — ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS2005-01-31

Adverse 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, 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 →

Recalls naming K133399

K-number listed on FDA's recall record

Z-2155-2014 — CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. 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.Class I·Terminated·Cardiovascular Systems, Inc.·20140523

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133399.

Data sourced from openFDA. This site is unofficial and independent of the FDA.