TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (K231168)
Description
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support by Imperative Care, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231168
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. TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (K231168) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212224 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Pl... | Imperative Care, Inc. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Pl... | Imperative Care, Inc. | 2024 |
Trace the full predicate network for K231168
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.