BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER— 510(k) K962921

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K962921 for BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER, Substantially Equivalent on 1996-10-09. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 1996-07-26
Decision date: 1996-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Covington, GA, US

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Adverse events under product code EZN

product code EZN

Death: 3
Injury: 127
Total: 130

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.