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FDA 510(k)

The ICHOR Panacea Vascular Embolectomy Catheter System

K-Number: K182167 · 2018-12-21

ApplicantIchor Vascular, Inc.
Decision Date2018-12-21
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

The ICHOR Panacea Vascular Embolectomy Catheter System is a medical device manufactured by Ichor Vascular, Inc.. It received FDA 510(k) clearance on 2018-12-21 under approval number K182167. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The ICHOR Panacea Vascular Embolectomy Catheter System?

The ICHOR Panacea Vascular Embolectomy Catheter System is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Ichor Vascular, Inc.. The 510(k) number is K182167.

When was The ICHOR Panacea Vascular Embolectomy Catheter System approved by the FDA?

The ICHOR Panacea Vascular Embolectomy Catheter System received FDA 510(k) clearance on 2018-12-21, under approval number K182167.

What company makes The ICHOR Panacea Vascular Embolectomy Catheter System?

The ICHOR Panacea Vascular Embolectomy Catheter System is manufactured by Ichor Vascular, Inc..

What is the FDA product code for The ICHOR Panacea Vascular Embolectomy Catheter System?

The FDA product code for The ICHOR Panacea Vascular Embolectomy Catheter System is QEW.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING

Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari Medical, 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.

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