MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM— 510(k) K081944

Name: FDA 510(k) clearance K081944
Creator: U.S. Food and Drug Administration
Published: 2008-08-14

Substantially Equivalent

Cardio Systems, Inc.

FDA 510(k) clearance K081944 for MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM, Substantially Equivalent on 2008-08-14. Applicant: Cardio Systems, Inc.. Device class: 2.

Clearance details

Applicant: Cardio Systems, Inc.
Product code: Code MCW
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 2008-07-08
Decision date: 2008-08-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MCW

view all

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 Cardio Systems, Inc.

view all

K131092 — STEALTH 360 ORBITAL PAD SYSTEM2013-06-24
K972022 — ZAK-20001998-01-22
K934689 — LOW AIR LOSS MATTRESS, MODIFICATION1994-02-02
K921500 — CENTRI-SAFE(TM) VALVE1992-09-15
K882177 — ADD-ON TO CRITICAL PATIENT CARE BED1988-12-01

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 →

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