The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Benchmark Bmx96 Access System.
| Device ID | K213390 |
| 510k Number | K213390 |
| Device Name: | Benchmark BMX96 Access System |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 95132 |
| Contact | Buu Buu Ly |
| Correspondent | Buu Buu Ly 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 | 2021-10-15 |
| Decision Date | 2022-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948026384 | K213390 | 000 |
| 00815948026223 | K213390 | 000 |
| 00815948026230 | K213390 | 000 |
| 00815948026247 | K213390 | 000 |
| 00815948026254 | K213390 | 000 |
| 00815948026261 | K213390 | 000 |
| 00815948026278 | K213390 | 000 |
| 00815948026285 | K213390 | 000 |
| 00815948026292 | K213390 | 000 |
| 00815948026308 | K213390 | 000 |
| 00815948026315 | K213390 | 000 |
| 00815948026322 | K213390 | 000 |
| 00815948026339 | K213390 | 000 |
| 00815948026346 | K213390 | 000 |
| 00815948026353 | K213390 | 000 |
| 00815948026360 | K213390 | 000 |
| 00815948026377 | K213390 | 000 |
| 00815948026216 | K213390 | 000 |