FDA 510(k) K211411, Penumbra System (RED 68 Reperfusion Catheter), by Penumbra, Inc.
FDA 510(k) K211411, Penumbra System (RED 68 Reperfusion Catheter), by Penumbra, Inc.
| 510(k) Number | K211411 |
| Device Classification Name | Catheter, Thrombus Retriever |
| Device Name | Penumbra System (RED 68 Reperfusion Catheter) |
| Applicant | Penumbra, Inc. One Penumbra Pl. Alameda, CA 95132 |
| Regulation Number | 870.125 |
| Classification Product Code | NRY |
| Date Received | 05/06/2021 |
| Decision Date | 07/01/2021 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Cardiovascular |
| 510k Review Panel | Neurology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 1296 |
| Redacted Pages | 1103 |
| Unredacted Pages | 193 |
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