Class Class II
Symphony Thrombectomy System (K223216)
Description
Symphony Thrombectomy System by Truvic Medical, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223216
Clearance Date2023-02-23
Clearance TypeTraditional
Product CodeQEW
Regulation Number870.5150
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223216
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 (K223216) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration S... | Penumbra, Inc. | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thromb... | Imperative Care, Inc. | 2025 |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombect... | Imperative Care, Inc. | 2025 |
Trace the full predicate network for K223216
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.