MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT— 510(k) K012584

Substantially Equivalent

FDA 510(k) clearance K012584 for MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT, Substantially Equivalent on 2001-09-06. Applicant: Bd.

Clearance details

Applicant: Bd
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 2001-08-10
Decision date: 2001-09-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Franklin Lakes, NJ, US

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Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.