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FDA 510(k)

Axium Detachable Coil; Axium Prime Detachable Coil

K-Number: K233420 · 2023-11-07

ApplicantMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Decision Date2023-11-07
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Axium Detachable Coil; Axium Prime Detachable Coil is a medical device manufactured by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. It received FDA 510(k) clearance on 2023-11-07 under approval number K233420. 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 Axium Detachable Coil; Axium Prime Detachable Coil?

Axium Detachable Coil; Axium Prime Detachable Coil is a medical device that received FDA 510(k) clearance on 2023-11-07. It is manufactured by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. The 510(k) number is K233420.

When was Axium Detachable Coil; Axium Prime Detachable Coil approved by the FDA?

Axium Detachable Coil; Axium Prime Detachable Coil received FDA 510(k) clearance on 2023-11-07, under approval number K233420.

What company makes Axium Detachable Coil; Axium Prime Detachable Coil?

Axium Detachable Coil; Axium Prime Detachable Coil is manufactured by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular.

What is the FDA product code for Axium Detachable Coil; Axium Prime Detachable Coil?

The FDA product code for Axium Detachable Coil; Axium Prime Detachable Coil is HCG.

Other Devices by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

K210230Phenom Catheters K241177React 71 Catheter

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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