Cleared Traditional

Symphony Thrombectomy System (K223216) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223216 · Truvic Medical, Inc. · Cardiovascular device
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Feb 2023
Decision
129d
Days
Class 2
Risk

K223216 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 Truvic Medical, Inc. (Campbell, US). The FDA issued a Cleared decision on February 23, 2023 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Truvic Medical, Inc. devices

Submission Details

510(k) Number K223216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2022
Decision Date February 23, 2023
Days to Decision 129 days
Submission Type Traditional
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
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Cardiomed Devices Consultants
Semih Oktay

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 120
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K223216.
RevCore™ Thrombectomy Catheter.
K223609 · Inari Medical, Inc. · Mar 2023
Protrieve Sheath
K230331 · Inari Medical, Inc. · Mar 2023
Artix AX
K223436 · Inari Medical · Mar 2023
Excipio LV Thrombectomy Device
K223897 · Contego Medical, Inc. · Feb 2023
Cobra Catheter System
K223891 · Endovascular Engineering · Feb 2023
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K223186 · Penumbra, Inc. · Feb 2023