PERFSCAPE— 510(k) K091444

Substantially Equivalent

Olea Medical

FDA 510(k) clearance K091444 for PERFSCAPE, Substantially Equivalent on 2009-07-20. Applicant: Olea Medical.

Clearance details

Applicant: Olea Medical
Product code: Code LNH
Advisory panel: Radiology
Date received: 2009-05-15
Decision date: 2009-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.