EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026— 510(k) K010162

Name: FDA 510(k) clearance K010162
Creator: U.S. Food and Drug Administration
Published: 2001-05-18

Substantially Equivalent

Micro Therapeutics, Inc.

FDA 510(k) clearance K010162 for EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026, Substantially Equivalent on 2001-05-18. Applicant: Micro Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Micro Therapeutics, Inc.
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 2001-01-17
Decision date: 2001-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.