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 Prime Detachable Coil System

K-Number: K162704 · 2017-01-03

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2017-01-03
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Axium Prime Detachable Coil System is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2017-01-03 under approval number K162704. 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 Prime Detachable Coil System?

Axium Prime Detachable Coil System is a medical device that received FDA 510(k) clearance on 2017-01-03. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K162704.

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

Axium Prime Detachable Coil System received FDA 510(k) clearance on 2017-01-03, under approval number K162704.

What company makes Axium Prime Detachable Coil System?

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

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

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

Related Clinical Trials

NCT03735667 ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement ACTIVE_NOT_RECRUITING NCT05608408 PRIME: PReservIng Memory in Epilepsy RECRUITING NCT05465161 STING MARK Universal Fiducial Marker System RECRUITING NCT06751355 Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial RECRUITING

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.

↑