COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT— 510(k) K992906

Name: FDA 510(k) clearance K992906
Creator: U.S. Food and Drug Administration
Published: 1999-11-10

Substantially Equivalent

Olson Medical Sales, Inc.

FDA 510(k) clearance K992906 for COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT, Substantially Equivalent on 1999-11-10. Applicant: Olson Medical Sales, Inc.. Device class: 2.

Clearance details

Applicant: Olson Medical Sales, Inc.
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 1999-08-30
Decision date: 1999-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.