K211411 is an FDA 510(k) clearance for the Penumbra System (RED 68 Reperfusion Catheter). This device is classified as a Catheter, Thrombus Retriever (Class II - Special Controls, product code NRY).
Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on July 1, 2021, 56 days after receiving the submission on May 6, 2021.
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 | K211411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2021 |
| Decision Date | July 01, 2021 |
| Days to Decision | 56 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. |