Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Axium Detachable Coil; Axium Prime Detachable Coil

K-Number: K203432 · 2021-07-07

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2021-07-07
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Axium Detachable Coil; Axium Prime Detachable Coil is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2021-07-07 under approval number K203432. 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 2021-07-07. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K203432.

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 2021-07-07, under approval number K203432.

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

Axium Detachable Coil; Axium Prime Detachable Coil is manufactured by Micro Therapeutics, Inc. 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, Inc. d/b/a ev3 Neurovascular

K162539Solitaire 2 Revascularization Device K161152Navien Intracranial Support Catheter K161879Solitaire Platinum Revascularization Device K172448Riptide Aspiration System K171268Reverse 021 Micro Catheter, Reverse 027 Micro Catheter K160641Solitaire Platinum Revascularization Device, 6x40 mm

View all 28 devices →

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.

↑