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FDA 510(k)

RevCore™ Thrombectomy Catheter.

K-Number: K223609 · 2023-03-14

ApplicantInari Medical, Inc.
Decision Date2023-03-14
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RevCore™ Thrombectomy Catheter. is the device name listed in this FDA 510(k) record. The listed applicant is Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-03-14 under 510(k) number K223609. 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 RevCore™ Thrombectomy Catheter.?

RevCore™ Thrombectomy Catheter. is a medical device that received FDA 510(k) clearance on 2023-03-14. The listed applicant is Inari Medical, Inc.. The 510(k) number is K223609.

When did RevCore™ Thrombectomy Catheter. receive FDA 510(k) clearance?

RevCore™ Thrombectomy Catheter. received FDA 510(k) clearance on 2023-03-14, under 510(k) number K223609.

Who is the listed applicant for RevCore™ Thrombectomy Catheter.?

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

What is the FDA product code for RevCore™ Thrombectomy Catheter.?

The FDA product code for RevCore™ Thrombectomy Catheter. is QEW.

Related Clinical Trials

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.

NCT06394739RevCore for In Stent ThrombosisRECRUITINGNCT05701917DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein ThrombosisRECRUITINGNCT06055920The PEERLESS II StudyACTIVE_NOT_RECRUITINGNCT06495996The Protrieve PROTECTOR StudyCOMPLETEDNCT06588634The PERSEVERE StudyRECRUITINGNCT06600542Inari VISION RegistryRECRUITING

Other records listing Inari 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.

K252508Intri26 Introducer SheathK253323Protrieve SheathK250421InThrill™ Thrombectomy SystemK250088FlowTriever2 CatheterK241894Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathK242557ClotTriever XL Catheter (41-102)

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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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