The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Benchmark Intracranial Access System.
| Device ID | K212838 |
| 510k Number | K212838 |
| Device Name: | Benchmark Intracranial Access System |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Buu Buu Ly |
| Correspondent | Buu Buu Ly Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-07 |
| Decision Date | 2022-05-27 |