Cleared Special

Protrieve Sheath

K253323 · Inari Medical · Cardiovascular

Oct 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K253323 is an FDA 510(k) clearance for the Protrieve Sheath, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Inari Medical (Irvine, US). The FDA issued a Cleared decision on October 29, 2025, 29 days after receiving the submission on September 30, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K253323 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2025
Decision Date	October 29, 2025
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEW — Peripheral Mechanical Thrombectomy With Aspiration
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.