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
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
| 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510(k) Summary PDF or remain unpublished.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