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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Triever Duo Catheter

FDA 510(k) source

510(k) number
K253419
Applicant
Inari Medical, Inc.
Decision date
Sep 18, 2026
Date received
Oct 1, 2025
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
QEW
Device type
Peripheral Mechanical Thrombectomy With Aspiration
Device class
Class II
Regulation
21 CFR 870.5150
Advisory committee
Cardiovascular
Statement or summary
Summary
Third party
N
Location
Irvine, CA, US