MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300— 510(k) K061063

Substantially Equivalent

Foxhollow Technologies, Inc.

FDA 510(k) clearance K061063 for MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300, Substantially Equivalent on 2006-05-18. Applicant: Foxhollow Technologies, Inc..

Clearance details

Applicant: Foxhollow Technologies, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2006-04-17
Decision date: 2006-05-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, 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.