The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Benchmark Bmx96 Access System.
| Device ID | K201271 |
| 510k Number | K201271 |
| Device Name: | Benchmark BMX96 Access System |
| Classification | Catheter, Percutaneous |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Matthew Benenati |
| Correspondent | Matthew Benenati Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-12 |
| Decision Date | 2020-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948023086 | K201271 | 000 |
| 00815948022614 | K201271 | 000 |
| 00815948022621 | K201271 | 000 |
| 00815948022638 | K201271 | 000 |
| 00815948022645 | K201271 | 000 |
| 00815948022652 | K201271 | 000 |
| 00815948022669 | K201271 | 000 |
| 00815948022676 | K201271 | 000 |
| 00815948022683 | K201271 | 000 |
| 00815948022690 | K201271 | 000 |
| 00815948022706 | K201271 | 000 |
| 00815948022713 | K201271 | 000 |
| 00815948023031 | K201271 | 000 |
| 00815948023048 | K201271 | 000 |
| 00815948023055 | K201271 | 000 |
| 00815948023062 | K201271 | 000 |
| 00815948023079 | K201271 | 000 |
| 00815948022607 | K201271 | 000 |