FDA 510(k)

FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24

K-Number: K211013 · 2021-04-30

Decision Date2021-04-30

Product CodeQEW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 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 2021-04-30 under 510(k) number K211013. 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 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24?

FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Inari Medical, Inc.. The 510(k) number is K211013.

When did FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 receive FDA 510(k) clearance?

FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 received FDA 510(k) clearance on 2021-04-30, under 510(k) number K211013.

Who is the listed applicant for FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24?

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 FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24?

The FDA product code for FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 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.

NCT05701917DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein ThrombosisRECRUITING NCT06055920The PEERLESS II StudyACTIVE_NOT_RECRUITING NCT06394739RevCore for In Stent ThrombosisRECRUITING NCT06495996The Protrieve PROTECTOR StudyCOMPLETED NCT06588634The PERSEVERE StudyRECRUITING NCT06600542Inari VISION RegistryRECRUITING

Other records listing Inari Medical, Inc. as applicant

K252508Intri26 Introducer Sheath K253323Protrieve Sheath K250421InThrill™ Thrombectomy System K250088FlowTriever2 Catheter K241894Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath K242557ClotTriever XL Catheter (41-102)

View all 54 devices →

Related Devices (Code: QEW)

K261523Vertex™ Thrombectomy SystemJupiter Endovascular K260599INDIGO® 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.