K243601 is an FDA 510(k) clearance for the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set. This device is classified as a Catheter, Thrombus Retriever (Class II - Special Controls, product code NRY).
Submitted by Route 92 Medical, Inc. (San Mateo, US). The FDA issued a Cleared decision on May 19, 2025, 179 days after receiving the submission on November 21, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250. The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode..
| 510(k) Number | K243601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2024 |
| Decision Date | May 19, 2025 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NRY - Catheter, Thrombus Retriever |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode. |