CHOLANGIOLAPCATH(TM)— 510(k) K921091

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K921091 for CHOLANGIOLAPCATH(TM), Substantially Equivalent on 1992-05-06. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic.

Clearance details

Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code
Code GBZ
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Franklin Lakes, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GBZ

product code GBZ
Death
2
Total
2

Source: openFDA MAUDE database, through . 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.