BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube— 510(k) K230493

Substantially Equivalent

Becton, Dickinson and Company

FDA 510(k) clearance K230493 for BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube, Substantially Equivalent on 2023-11-27. Applicant: Becton, Dickinson and Company.

Clearance details

Applicant
Becton, Dickinson and Company
Product code
Code GIM
Advisory panel
Clinical Chemistry
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 GIM

product code GIM
Malfunction
1,325
Total
1,325

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.