X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER— 510(k) K080944

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K080944 for X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER, Substantially Equivalent on 2008-10-23. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code LJE
Advisory panel: Unknown
Date received: 2008-04-03
Decision date: 2008-10-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Covington, GA, US

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Adverse events under product code LJE

product code LJE

Death: 6
Total: 6

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.