Cleared Special

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

K250775 · Imperative Care, Inc. · Cardiovascular

May 2025

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K250775 is an FDA 510(k) clearance for the Symphony? Thrombectomy System; 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 May 14, 2025, 61 days after receiving the submission on March 14, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K250775 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2025
Decision Date	May 14, 2025
Days to Decision	61 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.