Cleared Traditional

Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (K252057) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K252057 · Imperative Care, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
58d
Days
Class 2
Risk

K252057 is an FDA 510(k) clearance for the Symphony™ Thrombectomy System and Symphony™ 16F 82cm 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 August 28, 2025 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Imperative Care, Inc. devices

Submission Details

510(k) Number K252057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06062329 Completed Interventional Industry-sponsored

SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism

109
Patients (actual)
19
Sites
Treatment
Purpose
Open label
Masking
Condition studied Acute Pulmonary Embolism; Thromboembolism; Emboli, Pulmonary; Thrombosis; Thrombus; Embolism; Embolism; Cardiovascular Diseases; Vascular Diseases
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Imperative Care, Inc. (industry)
Started 2023-12-13 → Primary completion 2025-05-04 → Completed 2025-05-29
Primary outcome
Rate of major adverse events
Secondary outcome
Rates of Major bleeding, device-related mortality, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury
Study completed - no results published. This trial concluded in 2025 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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 K252057.
Protrieve Sheath
K253323 · Inari Medical · Oct 2025
Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)
K251185 · Intervene · Oct 2025
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing
K252612 · Penumbra, Inc. · Oct 2025
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