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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 the device name listed in this FDA 510(k) record. The listed applicant is Ichor Vascular, Inc.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) 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. The listed applicant is Ichor Vascular, Inc.. The 510(k) number is K182167.

When did The ICHOR Panacea Vascular Embolectomy Catheter System receive FDA 510(k) clearance?

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

Who is the listed applicant for The ICHOR Panacea Vascular Embolectomy Catheter System?

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

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 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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