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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 a medical device manufactured by Inari Medical. It received FDA 510(k) clearance on 2025-10-29 under approval 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. It is manufactured by Inari Medical. The 510(k) number is K253323.

When was Protrieve Sheath approved by the FDA?

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

What company makes Protrieve Sheath?

Protrieve Sheath is manufactured by Inari Medical.

What is the FDA product code for Protrieve Sheath?

The FDA product code for Protrieve Sheath is QEW.

Related Clinical Trials

NCT06495996 The Protrieve PROTECTOR Study COMPLETED NCT06600542 Inari VISION Registry RECRUITING NCT06453876 Percutaneous Embolectomy, Low Dose Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism (STRATIFY II) NOT_YET_RECRUITING

Other Devices by Inari Medical

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath K183198FlowTriever Retrieval/Aspiration System K182233FlowTriever Retrieval/Aspiration System K182531ClotTriever Thrombectomy System K181694FlowTriever Retrieval/Aspiration System

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Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari Medical, Inc.

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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