BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER— 510(k) K043371

Substantially Equivalent

Biomerix Corporation

FDA 510(k) clearance K043371 for BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER, Substantially Equivalent on 2005-02-03. Applicant: Biomerix Corporation.

Clearance details

Applicant: Biomerix Corporation
Product code: Code KRD
Advisory panel: Cardiovascular
Date received: 2004-12-08
Decision date: 2005-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRD

product code KRD

Death: 119
Injury: 1,869
Malfunction: 7,015
Other: 1
Total: 9,004

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.