GUARDIANCATHETER-URINARY DRAINAGE CATHETER— 510(k) K063795

Substantially Equivalent

Marian Medical, Inc.

FDA 510(k) clearance K063795 for GUARDIANCATHETER-URINARY DRAINAGE CATHETER, Substantially Equivalent on 2007-03-05. Applicant: Marian Medical, Inc..

Clearance details

Applicant: Marian Medical, Inc.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 2006-12-22
Decision date: 2007-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

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Adverse events under product code GBM

product code GBM

Injury: 397
Malfunction: 1,404
Total: 1,801

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.