SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS— 510(k) K831401

Name: FDA 510(k) clearance K831401
Creator: U.S. Food and Drug Administration
Published: 1983-06-03

Substantially Equivalent

Med-West, Inc.

FDA 510(k) clearance K831401 for SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS, Substantially Equivalent on 1983-06-03. Applicant: Med-West, Inc.. Device class: 2.

Clearance details

Applicant: Med-West, Inc.
Product code: Code FIQ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1983-05-02
Decision date: 1983-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.