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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 the device name listed in this FDA 510(k) record. The listed applicant is Ichor. It received FDA 510(k) clearance on 2023-09-05 under 510(k) 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. The listed applicant is Ichor. The 510(k) number is K230743.

When did ICHOR 14F Embolectomy System receive FDA 510(k) clearance?

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

Who is the listed applicant for ICHOR 14F Embolectomy System?

The FDA 510(k) record lists Ichor as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ichor as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233917ICHOR 7F Embolectomy System (ICH-7F)

Related Devices (Code: QEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular 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.

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