Class Class II
Zoom System (K242672)
Description
Zoom System by Imperative Care, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242672
Clearance Date2025-01-14
Clearance TypeTraditional
Product CodeNRY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242672
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. Zoom System (K242672) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Pl... | Imperative Care, Inc. | 2024 |
| K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2021 |
| K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiratio... | Imperative Care, Inc. | 2021 |
Trace the full predicate network for K242672
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.