VITAL-PORT MINI VASCULAR ACCESS SYSTEM— 510(k) K931586

Name: FDA 510(k) clearance K931586
Creator: U.S. Food and Drug Administration
Published: 1993-09-27

Unknown

Med Institute, Inc.

FDA 510(k) clearance K931586 for VITAL-PORT MINI VASCULAR ACCESS SYSTEM, Unknown on 1993-09-27. Applicant: Med Institute, Inc.. Device class: 2.

Clearance details

Applicant: Med Institute, Inc.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 1993-03-31
Decision date: 1993-09-27
Decision: Unknown
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.