NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000— 510(k) K090932

Substantially Equivalent

Nexgen Medical Systems, Inc.

FDA 510(k) clearance K090932 for NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000, Substantially Equivalent on 2009-09-24. Applicant: Nexgen Medical Systems, Inc..

Clearance details

Applicant: Nexgen Medical Systems, Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2009-04-02
Decision date: 2009-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

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.