BARD ELIMINATOR PET BALLOON DILATORS— 510(k) K033936

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K033936 for BARD ELIMINATOR PET BALLOON DILATORS, Substantially Equivalent on 2004-01-14. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 2003-12-19
Decision date: 2004-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Billerica, MA, US

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Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

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.