The following data is part of a premarket notification filed by Penumbra, Inc with the FDA for Benchmark Bmx81 Access System.
| Device ID | K221822 |
| 510k Number | K221822 |
| Device Name: | BENCHMARK BMX81 Access System |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Penumbra, Inc One Penumbra Place Alameda, CA 95132 |
| Contact | Sindokht (Sisi) Soltanzadeh |
| Correspondent | Sindokht Soltanzadeh Penumbra, Inc One Penumbra Place Alameda, CA 95132 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-23 |
| Decision Date | 2022-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948024670 | K221822 | 000 |
| 00815948024519 | K221822 | 000 |
| 00815948024526 | K221822 | 000 |
| 00815948024533 | K221822 | 000 |
| 00815948024540 | K221822 | 000 |
| 00815948024557 | K221822 | 000 |
| 00815948024564 | K221822 | 000 |
| 00815948024571 | K221822 | 000 |
| 00815948024588 | K221822 | 000 |
| 00815948024595 | K221822 | 000 |
| 00815948024601 | K221822 | 000 |
| 00815948024618 | K221822 | 000 |
| 00815948024625 | K221822 | 000 |
| 00815948024632 | K221822 | 000 |
| 00815948024649 | K221822 | 000 |
| 00815948024656 | K221822 | 000 |
| 00815948024663 | K221822 | 000 |
| 00815948024502 | K221822 | 000 |