VICOR PD2I ANALYZER— 510(k) K101867

Name: FDA 510(k) clearance K101867
Creator: U.S. Food and Drug Administration
Published: 2011-04-14

Substantially Equivalent

Vicor Technologies, Inc.

FDA 510(k) clearance K101867 for VICOR PD2I ANALYZER, Substantially Equivalent on 2011-04-14. Applicant: Vicor Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Vicor Technologies, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2010-07-02
Decision date: 2011-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.