Cleared Traditional

Symphony? Thrombectomy System and Symphony? 16F 82cm Thrombectomy System

K252057 · Imperative Care, Inc. · Cardiovascular

Aug 2025

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K252057 is an FDA 510(k) clearance for the Symphony? Thrombectomy System and Symphony? 16F 82cm Thrombectomy System, a Peripheral Mechanical Thrombectomy With Aspiration (Class II — Special Controls, product code QEW), submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on August 28, 2025, 58 days after receiving the submission on July 1, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K252057 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2025
Decision Date	August 28, 2025
Days to Decision	58 days
Submission Type	Traditional
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.