VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM— 510(k) K933386

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K933386 for VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM, Substantially Equivalent on 1993-10-12. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code
Code GIM
Device class
Class 2
Regulation
21 CFR 862.1675
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Franklin Lake, NJ, US
Download summary PDFView on FDA.gov ↗

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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.