HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)— 510(k) K091641

Substantially Equivalent

MicroVention, Inc.

FDA 510(k) clearance K091641 for HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT), Substantially Equivalent on 2009-06-30. Applicant: MicroVention, Inc..

Clearance details

Applicant: MicroVention, Inc.
Product code: Code HCG
Advisory panel: Neurology
Date received: 2009-06-04
Decision date: 2009-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Aliso Viejo, CA, US

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Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.