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FDA 510(k)

ICE Aspiration System

K-Number: K234073 · 2024-04-19

ApplicantExpanse Medical, Inc.
Decision Date2024-04-19
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ICE Aspiration System is the device name listed in this FDA 510(k) record. The listed applicant is Expanse Medical, Inc.. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K234073. 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 ICE Aspiration System?

ICE Aspiration System is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Expanse Medical, Inc.. The 510(k) number is K234073.

When did ICE Aspiration System receive FDA 510(k) clearance?

ICE Aspiration System received FDA 510(k) clearance on 2024-04-19, under 510(k) number K234073.

Who is the listed applicant for ICE Aspiration System?

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

What is the FDA product code for ICE Aspiration System?

The FDA product code for ICE Aspiration System is QEW.

Other records listing Expanse Medical, Inc. 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.

K254208FLOWRUNNER Aspiration SystemK251488FLOWRUNNER Aspiration System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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