ISIRONA MAGELLAN— 510(k) K130707

Name: FDA 510(k) clearance K130707
Creator: U.S. Food and Drug Administration
Published: 2013-11-20

Substantially Equivalent

Isirona, LLC

FDA 510(k) clearance K130707 for ISIRONA MAGELLAN, Substantially Equivalent on 2013-11-20. Applicant: Isirona, LLC. Device class: 2.

Clearance details

Applicant: Isirona, LLC
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2013-03-15
Decision date: 2013-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nederland, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.