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FDA 510(k)

Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System

K-Number: K252057 · 2025-08-28

ApplicantImperative Care, Inc.
Decision Date2025-08-28
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2025-08-28 under 510(k) 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. The listed applicant is Imperative Care, Inc.. The 510(k) number is K252057.

When did Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System receive FDA 510(k) clearance?

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

Who is the listed applicant for Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System?

The FDA 510(k) record lists Imperative Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06062329SYMPHONY-PE Study for Treatment of Pulmonary EmbolismCOMPLETEDNCT07350499Aspiration Thrombectomy Using the Symphony or Prodigy SystemRECRUITINGNCT07491952Continuous Dual Aspiration Technique With Zoom System for StrokeRECRUITING

Other records listing Imperative Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252046Zoom System (Zoom 4S Catheter)K244061X-Wire GuidewireK243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingK250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemK242672Zoom SystemK240948TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support

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Related Devices (Code: QEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation

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.

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