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)

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)

K-Number: K222694 · 2023-04-27

ApplicantMicroVention, Inc.
Decision Date2023-04-27
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2023-04-27 under approval number K222694. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)?

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) is a medical device that received FDA 510(k) clearance on 2023-04-27. It is manufactured by MicroVention, Inc.. The 510(k) number is K222694.

When was EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) approved by the FDA?

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) received FDA 510(k) clearance on 2023-04-27, under approval number K222694.

What company makes EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)?

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) is manufactured by MicroVention, Inc..

What is the FDA product code for EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)?

The FDA product code for EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) is NTE.

Other Devices by MicroVention, Inc.

K163154Traxcess 7 Mini XSoft Guidewire K161803Traxcess .007 Mini Guidewire K161367HydroCoil Embolic System (HES) K161452MicroPlex Coil System (MCS) - HyperSoft 3D K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System

View all 28 devices →

Related Devices (Code: NTE)

K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. K180023WIRIONGardia Medical , Ltd. K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular K200198WIRIONCardiovascular Systems, Inc. K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc. K220654ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture GuidewireCordis Corporation

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.

↑