Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (K243047)
Description
Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing by Imperative Care, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243047
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 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (K243047) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2021 |
Trace the full predicate network for K243047
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.