The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Benchmark Intracranial Access System.
| Device ID | K142321 |
| 510k Number | K142321 |
| Device Name: | Benchmark Intracranial Access System |
| Classification | Catheter, Percutaneous |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Contact | Michaela Mahl |
| Correspondent | Michaela Mahl PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-19 |
| Decision Date | 2015-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548014241 | K142321 | 000 |
| 00814548014043 | K142321 | 000 |
| 00814548014036 | K142321 | 000 |
| 00814548014029 | K142321 | 000 |
| 00814548014012 | K142321 | 000 |
| 00815948025257 | K142321 | 000 |
| 00815948025240 | K142321 | 000 |
| 00815948025233 | K142321 | 000 |
| 00815948025226 | K142321 | 000 |
| 00815948025219 | K142321 | 000 |
| 00815948025202 | K142321 | 000 |
| 00815948025196 | K142321 | 000 |
| 00815948025189 | K142321 | 000 |
| 00815948025172 | K142321 | 000 |
| 00815948025165 | K142321 | 000 |
| 00815948025158 | K142321 | 000 |
| 00815948025141 | K142321 | 000 |
| 00815948025134 | K142321 | 000 |
| 00814548014050 | K142321 | 000 |
| 00814548014067 | K142321 | 000 |
| 00814548014234 | K142321 | 000 |
| 00814548014227 | K142321 | 000 |
| 00814548014210 | K142321 | 000 |
| 00814548014203 | K142321 | 000 |
| 00814548014197 | K142321 | 000 |
| 00814548014180 | K142321 | 000 |
| 00814548014173 | K142321 | 000 |
| 00814548014166 | K142321 | 000 |
| 00814548014159 | K142321 | 000 |
| 00814548014142 | K142321 | 000 |
| 00814548014135 | K142321 | 000 |
| 00814548014128 | K142321 | 000 |
| 00814548014111 | K142321 | 000 |
| 00814548014104 | K142321 | 000 |
| 00814548014098 | K142321 | 000 |
| 00814548014081 | K142321 | 000 |
| 00814548014074 | K142321 | 000 |
| 00815948025127 | K142321 | 000 |