FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH— 510(k) K050889

Substantially Equivalent

Crs Medical Diagnostics, Inc.

FDA 510(k) clearance K050889 for FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH, Substantially Equivalent on 2005-08-26. Applicant: Crs Medical Diagnostics, Inc..

Clearance details

Applicant: Crs Medical Diagnostics, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2005-04-06
Decision date: 2005-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pewaukee, WI, US

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Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.