MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO— 510(k) K103780

Substantially Equivalent

Micrus Endovascular Corporation

FDA 510(k) clearance K103780 for MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO, Substantially Equivalent on 2011-01-26. Applicant: Micrus Endovascular Corporation.

Clearance details

Applicant: Micrus Endovascular Corporation
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2010-12-27
Decision date: 2011-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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.