DeviceClearance

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System— 510(k) K172386

Substantially Equivalent

Volcano Atheromed, Inc.

FDA 510(k) clearance K172386 for 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System, Substantially Equivalent on 2017-08-24. 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
Download summary PDFView on FDA.gov ↗

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More clearances from Volcano Atheromed, Inc.

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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.