NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE— 510(k) K110315

Substantially Equivalent

Nexgen Medical Systems, Inc.

FDA 510(k) clearance K110315 for NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE, Substantially Equivalent on 2011-10-20. Applicant: Nexgen Medical Systems, Inc..

Clearance details

Applicant: Nexgen Medical Systems, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2011-02-02
Decision date: 2011-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

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.