Verrata PLUS Pressure Guide Wire— 510(k) K210235

Substantially Equivalent

Volcano Corporation

FDA 510(k) clearance K210235 for Verrata PLUS Pressure Guide Wire, Substantially Equivalent on 2021-04-15. Applicant: Volcano Corporation.

Clearance details

Applicant: Volcano Corporation
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2021-01-28
Decision date: 2021-04-15
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.