Class Class II

Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (K252057)

K252057 2025-08-28 Traditional
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Description

Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System by Imperative Care, Inc., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252057
Clearance Date2025-08-28
Clearance TypeTraditional
Product CodeQEW
Regulation Number870.5150

Categories

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Predicate lineage for K252057

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System (K252057) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombect...Imperative Care, Inc.2025
K223216Symphony Thrombectomy SystemTruvic Medical, Inc.2023

Trace the full predicate network for K252057

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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