B-D ANGIOGRAPHIC CONTROL SYRINGE— 510(k) K895318

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K895318 for B-D ANGIOGRAPHIC CONTROL SYRINGE, Substantially Equivalent on 1990-01-19. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1989-08-29
Decision date: 1990-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.