THE DART— 510(k) K905549

Name: FDA 510(k) clearance K905549
Creator: U.S. Food and Drug Administration
Published: 1991-02-19

Substantially Equivalent

Dexide, Inc.

FDA 510(k) clearance K905549 for THE DART, Substantially Equivalent on 1991-02-19. Applicant: Dexide, Inc.. Device class: 2.

Clearance details

Applicant: Dexide, Inc.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 1990-12-11
Decision date: 1991-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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K981940 — MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES1998-09-25
K981941 — MULTAPORT CANNULA REDUCER AND ACCESSORIES1998-07-29
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Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.