VACUTAINER BRAND CTAD TUBE (MULTIPLE)— 510(k) K991120

Substantially Equivalent

Becton Dickinson Vacutainer Systems

FDA 510(k) clearance K991120 for VACUTAINER BRAND CTAD TUBE (MULTIPLE), Substantially Equivalent on 1999-05-19. Applicant: Becton Dickinson Vacutainer Systems.

Clearance details

Applicant: Becton Dickinson Vacutainer Systems
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1999-04-02
Decision date: 1999-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

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Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.