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FDA 510(k)

Wallaby Avenir Coil System

K-Number: K173711 · 2018-05-04

ApplicantWallaby Medical, Inc.
Decision Date2018-05-04
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Wallaby Avenir Coil System is a medical device manufactured by Wallaby Medical, Inc.. It received FDA 510(k) clearance on 2018-05-04 under approval number K173711. 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 Wallaby Avenir Coil System?

Wallaby Avenir Coil System is a medical device that received FDA 510(k) clearance on 2018-05-04. It is manufactured by Wallaby Medical, Inc.. The 510(k) number is K173711.

When was Wallaby Avenir Coil System approved by the FDA?

Wallaby Avenir Coil System received FDA 510(k) clearance on 2018-05-04, under approval number K173711.

What company makes Wallaby Avenir Coil System?

Wallaby Avenir Coil System is manufactured by Wallaby Medical, Inc..

What is the FDA product code for Wallaby Avenir Coil System?

The FDA product code for Wallaby Avenir Coil System is HCG.

Other Devices by Wallaby Medical, Inc.

K2226036F Wallaby Long Sheath

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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