K193063 is an FDA 510(k) clearance for the EMBOTRAP III Revascularization Device. This device is classified as a Catheter, Thrombus Retriever (Class II - Special Controls, product code NRY).
Submitted by Neuravi, Ltd. (Galway, IE). The FDA issued a Cleared decision on July 14, 2020, 253 days after receiving the submission on November 4, 2019.
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 | K193063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2019 |
| Decision Date | July 14, 2020 |
| Days to Decision | 253 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. |