BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM— 510(k) K090759

Substantially Equivalent

Biodrain Medical, Inc.

FDA 510(k) clearance K090759 for BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM, Substantially Equivalent on 2009-04-01. Applicant: Biodrain Medical, Inc..

Clearance details

Applicant: Biodrain Medical, Inc.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2009-03-23
Decision date: 2009-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mendota Heights, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.