Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (K243601)
Description
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set by Route 92 Medical, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243601
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. Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (K243601) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223530 | Route 92 Medical Full Length 070 Reperfusion System and Asp... | Route 92 Medical, Inc. | 2023 |
| K203043 | Route 92 Medical 070 Access System | Route 92 Medical, Inc. | 2020 |
| K201518 | Route 92 Medical 088 Access System | Route 92 Medical | 2020 |
| K191768 | AXS Vecta Aspiration System | Stryker Neurovascular | 2019 |
Trace the full predicate network for K243601
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.