MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10— 510(k) K103758

Name: FDA 510(k) clearance K103758
Creator: U.S. Food and Drug Administration
Published: 2011-04-28

Substantially Equivalent

MicroVention, Inc.

FDA 510(k) clearance K103758 for MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10, Substantially Equivalent on 2011-04-28. Applicant: MicroVention, Inc.. Device class: 2.

Clearance details

Applicant: MicroVention, Inc.
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2010-12-23
Decision date: 2011-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Tistin, CA, US

Download summary PDF View on FDA.gov ↗

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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 →

Recalls naming K103758

K-number listed on FDA's recall record

Z-1402-2020 — MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V, 100510HFRM-V, 100515HFRM-V, 100519HFRM-V, 100612HFRM-V, 100619HFRM-V, 100623HFRM-V, 100715HFRM-V, 100728HFRM-V, 100817HFRM-V, 100833HFRM-V, 100931HFRM-V; 101036HFRM-V, MV-00408HHFA, MV-00510HHFA, MV-00515HHFA, and MV-00619HHFA. Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.Class II·Terminated·Microvention, Inc.·20191122

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103758.

Data sourced from openFDA. This site is unofficial and independent of the FDA.