BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP— 510(k) K945813
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K945813 for BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP, Substantially Equivalent on 1995-02-07. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic.
Clearance details
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Product code
- Code FCG
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
Adverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
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.