PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA— 510(k) K132682

Substantially Equivalent

Atheromed, Inc.

FDA 510(k) clearance K132682 for PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA, Substantially Equivalent on 2014-01-17. Applicant: Atheromed, Inc..

Clearance details

Applicant: Atheromed, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2013-08-28
Decision date: 2014-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

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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, 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.