BARD UROTRACK II MONITORING— 510(k) K924436

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K924436 for BARD UROTRACK II MONITORING, Substantially Equivalent on 1994-03-15. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1992-09-01
Decision date: 1994-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.