1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP— 510(k) K140944

Name: FDA 510(k) clearance K140944
Creator: U.S. Food and Drug Administration
Published: 2014-08-22

Substantially Equivalent

Atheromed, Inc.

FDA 510(k) clearance K140944 for 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP, Substantially Equivalent on 2014-08-22. Applicant: Atheromed, Inc.. Device class: 2.

Clearance details

Applicant: Atheromed, Inc.
Product code: Code MCW
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 2014-04-14
Decision date: 2014-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Menlo Park, CA, 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 Atheromed, Inc.

view all

K132682 — PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA2014-01-17

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.