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)

Artemis Neuro Evacuation Device

K-Number: K171332 · 2017-08-14

ApplicantPenumbra, Inc.
Decision Date2017-08-14
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Artemis Neuro Evacuation Device is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2017-08-14 under approval number K171332. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Artemis Neuro Evacuation Device?

Artemis Neuro Evacuation Device is a medical device that received FDA 510(k) clearance on 2017-08-14. It is manufactured by Penumbra, Inc.. The 510(k) number is K171332.

When was Artemis Neuro Evacuation Device approved by the FDA?

Artemis Neuro Evacuation Device received FDA 510(k) clearance on 2017-08-14, under approval number K171332.

What company makes Artemis Neuro Evacuation Device?

Artemis Neuro Evacuation Device is manufactured by Penumbra, Inc..

What is the FDA product code for Artemis Neuro Evacuation Device?

The FDA product code for Artemis Neuro Evacuation Device is GWG.

Related Clinical Trials

NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT02098265 A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device RECRUITING NCT02896348 Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors RECRUITING NCT06982820 Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia RECRUITING NCT06292299 The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study RECRUITING NCT07510074 Modulating Inflammation in Neuro-Trauma NOT_YET_RECRUITING

Other Devices by Penumbra, Inc.

K161506Penumbra Aspiration System K161640Penumbra System ACE 68 Reperfusion Catheter K161523INDIGO Aspiration System K161064Penumbra System ACE 68 Reperfusion Catheter K160449Penumbra System, Penumbra Pump MAX K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

View all 59 devices →

Related Devices (Code: GWG)

K161112KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. K152699Apollo SystemPenumbra, Inc. K170667QEVO System with KINEVO 900Carl Zeiss Meditec, AG K170462KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc. K162880TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. K181731MR Compatible Aspiration KitMri Interventions, Inc.

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.

↑