Percutaneous Introducer— 510(k) K200624

Name: FDA 510(k) clearance K200624
Creator: U.S. Food and Drug Administration
Published: 2020-04-27

Substantially Equivalent

Epimed International, Inc.

FDA 510(k) clearance K200624 for Percutaneous Introducer, Substantially Equivalent on 2020-04-27. Applicant: Epimed International, Inc.. Device class: 2.

Clearance details

Applicant: Epimed International, Inc.
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 2020-03-10
Decision date: 2020-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmers Branch, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.