Cleared Special

Symphony™ Thrombectomy System (K250775) - FDA 510(k) Clearance

Also marketed or referenced as:
Symphony™ 16F 82cm Thrombectomy System

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250775 · Imperative Care, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
61d
Days
Class 2
Risk

K250775 is an FDA 510(k) clearance for the Symphony™ Thrombectomy System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on May 14, 2025 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Imperative Care, Inc. devices

Submission Details

510(k) Number K250775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 118
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K250775.
Aventus Thrombectomy System
K251189 · Inquis Medical · Jun 2025
Excipio LV Prime Thrombectomy Device
K251485 · Contego Medical, Inc. · Jun 2025
Liberant Thrombectomy System
K250787 · Medtronic, Ireland · Jun 2025
InThrill™ Thrombectomy System
K250421 · Inari Medical, Inc. · May 2025
Aventus Thrombectomy System (IM-2100)
K250668 · Inquis Medical · Mar 2025
FlowTriever2 Catheter
K250088 · Inari Medical, Inc. · Mar 2025