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FDA 510(k)

ICHOR 14F Embolectomy System

K-Number: K230743 · 2023-09-05

ApplicantIchor
Decision Date2023-09-05
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ICHOR 14F Embolectomy System is a medical device manufactured by Ichor. It received FDA 510(k) clearance on 2023-09-05 under approval number K230743. 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 ICHOR 14F Embolectomy System?

ICHOR 14F Embolectomy System is a medical device that received FDA 510(k) clearance on 2023-09-05. It is manufactured by Ichor. The 510(k) number is K230743.

When was ICHOR 14F Embolectomy System approved by the FDA?

ICHOR 14F Embolectomy System received FDA 510(k) clearance on 2023-09-05, under approval number K230743.

What company makes ICHOR 14F Embolectomy System?

ICHOR 14F Embolectomy System is manufactured by Ichor.

What is the FDA product code for ICHOR 14F Embolectomy System?

The FDA product code for ICHOR 14F Embolectomy System is QEW.

Related Clinical Trials

NCT06571760 Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I COMPLETED NCT06453876 Percutaneous Embolectomy, Low Dose Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism (STRATIFY II) NOT_YET_RECRUITING NCT06576427 Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II COMPLETED NCT07508553 Comparison of Bone Mineral Density in the Third Trimester Between Women in Singleton and Twin Pregnancies Using Questionnaires and REMS Densitometric Examination RECRUITING

Other Devices by Ichor

K233917ICHOR 7F Embolectomy System (ICH-7F)

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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