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MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX

K111451 Class II Traditional
Decision Date
2011-09-20
Sponsor / Applicant
MicroVention, Inc.

Technical Specification

510(k) Submission ID K111451
Product Code HCG
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5950
Decision Date 2011-09-20
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX received FDA 510(k) clearance under submission number K111451, sponsored by MicroVention, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-09-20.

Classification & Regulation

This clearance is catalogued under FDA product code HCG and 21 CFR 882.5950, within the Neurology review panel as a Class II device.