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FDA 510(k)

Protrieve Sheath

K-Number: K253323 · 2025-10-29

ApplicantInari Medical
Decision Date2025-10-29
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Protrieve Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Inari Medical. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K253323. 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 Protrieve Sheath?

Protrieve Sheath is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Inari Medical. The 510(k) number is K253323.

When did Protrieve Sheath receive FDA 510(k) clearance?

Protrieve Sheath received FDA 510(k) clearance on 2025-10-29, under 510(k) number K253323.

Who is the listed applicant for Protrieve Sheath?

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

What is the FDA product code for Protrieve Sheath?

The FDA product code for Protrieve Sheath 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.

NCT06495996The Protrieve PROTECTOR StudyCOMPLETEDNCT05701917DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein ThrombosisRECRUITINGNCT06055920The PEERLESS II StudyACTIVE_NOT_RECRUITINGNCT06394739RevCore for In Stent ThrombosisRECRUITINGNCT06588634The PERSEVERE StudyRECRUITINGNCT06600542Inari VISION RegistryRECRUITING

Other records listing Inari Medical 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 SheathK250421InThrill™ Thrombectomy SystemK250088FlowTriever2 CatheterK241894Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathK242557ClotTriever XL Catheter (41-102)K233069Removal System Large Bore 60 cc Syringe

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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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