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FDA 510(k)

Spartan eCoil System

K-Number: K180653 · 2018-12-04

ApplicantSpartan Micro, Inc.
Decision Date2018-12-04
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spartan eCoil System is a medical device manufactured by Spartan Micro, Inc.. It received FDA 510(k) clearance on 2018-12-04 under approval number K180653. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spartan eCoil System?

Spartan eCoil System is a medical device that received FDA 510(k) clearance on 2018-12-04. It is manufactured by Spartan Micro, Inc.. The 510(k) number is K180653.

When was Spartan eCoil System approved by the FDA?

Spartan eCoil System received FDA 510(k) clearance on 2018-12-04, under approval number K180653.

What company makes Spartan eCoil System?

Spartan eCoil System is manufactured by Spartan Micro, Inc..

What is the FDA product code for Spartan eCoil System?

The FDA product code for Spartan eCoil System is HCG.

Other Devices by Spartan Micro, Inc.

K220716Spartan SC 069 K220075Spartan Center Wire

Related Devices (Code: HCG)

K161367HydroCoil Embolic System (HES)MicroVention, Inc. K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc. K161429Target Detachable CoilsStryker Neurovascular K153658Target Detachable CoilsStryker Neurovascular K160832Penumbra Smart CoilPenumbra, Inc. K160096InZone Detachment SystemStryker Neurovascular

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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