I.V. STARTPAK VASCULAR ACCESS START KIT— 510(k) K942238

Name: FDA 510(k) clearance K942238
Creator: U.S. Food and Drug Administration
Published: 1994-06-03

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K942238 for I.V. STARTPAK VASCULAR ACCESS START KIT, Substantially Equivalent on 1994-06-03. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code LRS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1994-05-09
Decision date: 1994-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandy, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRS

product code LRS

Other: 2
Total: 2

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.