1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip— 510(k) K143328
Substantially EquivalentVolcano Atheromed, Inc.
FDA 510(k) clearance K143328 for 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip, Substantially Equivalent on 2014-12-19. Applicant: Volcano Atheromed, Inc.. Device class: 2.
Clearance details
- Applicant
- Volcano Atheromed, 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
- Menlo Park, CA, US
Recent devices under product code MCW
view allMore clearances from Volcano Atheromed, Inc.
view all- K211518 — 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
- K193197 — QuickClear Mechanical Thrombectomy System
- K182972 — Phoenix Atherectomy System
- K181877 — Phoenix 2.4mm Atherectomy Plus System
- K172386 — 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
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, 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.