FDA 510(k)

Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System

K-Number: K252057 · 2025-08-28

Decision Date2025-08-28

Product CodeQEW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System is a medical device manufactured by Imperative Care, Inc.. It received FDA 510(k) clearance on 2025-08-28 under approval number K252057. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System?

Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System is a medical device that received FDA 510(k) clearance on 2025-08-28. It is manufactured by Imperative Care, Inc.. The 510(k) number is K252057.

When was Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System approved by the FDA?

Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System received FDA 510(k) clearance on 2025-08-28, under approval number K252057.

What company makes Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System?

Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System is manufactured by Imperative Care, Inc..

What is the FDA product code for Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System?

The FDA product code for Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System is QEW.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING NCT07335341 Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System RECRUITING NCT07135895 The ArtixASCEND Study RECRUITING

Other Devices by Imperative Care, Inc.

K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length K1830430.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

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Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.