K222786 is an FDA 510(k) clearance for the 072 Aspiration System. This device is classified as a Catheter, Thrombus Retriever (Class II - Special Controls, product code NRY).
Submitted by Q'Apel Medical, Inc. (Fremont, US). The FDA issued a Cleared decision on August 25, 2023, 344 days after receiving the submission on September 15, 2022.
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 | K222786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2022 |
| Decision Date | August 25, 2023 |
| Days to Decision | 344 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. |