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Protrieve Sheath

by Inari Medical

510(k) K253323

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK253323 Date29 Oct 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QEW
Device class
Class II
Regulation
21 CFR Part 870.5150
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Protrieve Sheath is a device intended for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions. It features a wall-approaching funnel designed to trap emboli during complex DVT or IVC thrombectomy procedures.

The Protrieve Sheath is supplied as a single-use device and is not MRI safe. It is specifically designed for optimal clot removal with minimal blood loss and features a self-expanding nitinol funnel designed for 360º wall apposition. The device has received FDA 510(k) clearance with product code QEW.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Protrieve Sheath used for?

    The Protrieve Sheath is designed as a conduit for inserting endovascular devices into the vasculature while minimizing blood loss during complex DVT or IVC thrombectomy procedures. It features a wall-approaching funnel to trap emboli.

  • Is the Protrieve Sheath reusable or single-use?

    The Protrieve Sheath is supplied as a single-use device and is not MRI safe. It is specifically designed for optimal clot removal with minimal blood loss.

  • What regulatory clearance has the Protrieve Sheath received?

    The Protrieve Sheath has received FDA 510(k) clearance with product code QEW. It is classified as a Class II device for Peripheral Mechanical Thrombectomy With Aspiration.

  • What are the key features of the Protrieve Sheath?

    The Protrieve Sheath features a self-expanding nitinol funnel designed for 360º wall apposition, which helps trap emboli during complex DVT or IVC thrombectomy procedures while minimizing blood loss.