The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Neuron Max System.
| Device ID | K111380 |
| 510k Number | K111380 |
| Device Name: | NEURON MAX 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2011-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548012377 | K111380 | 000 |
| 00814548012216 | K111380 | 000 |
| 00814548012209 | K111380 | 000 |
| 00814548012193 | K111380 | 000 |
| 00814548012186 | K111380 | 000 |
| 00814548012179 | K111380 | 000 |
| 00814548012162 | K111380 | 000 |
| 00814548012155 | K111380 | 000 |
| 00814548012148 | K111380 | 000 |
| 00815948022409 | K111380 | 000 |
| 00815948022393 | K111380 | 000 |
| 00815948022386 | K111380 | 000 |
| 00815948022379 | K111380 | 000 |
| 00815948022362 | K111380 | 000 |
| 00814548012223 | K111380 | 000 |
| 00814548012230 | K111380 | 000 |
| 00814548012360 | K111380 | 000 |
| 00814548012353 | K111380 | 000 |
| 00814548012346 | K111380 | 000 |
| 00814548012339 | K111380 | 000 |
| 00814548012322 | K111380 | 000 |
| 00814548012315 | K111380 | 000 |
| 00814548012308 | K111380 | 000 |
| 00814548012292 | K111380 | 000 |
| 00814548012285 | K111380 | 000 |
| 00814548012278 | K111380 | 000 |
| 00814548012261 | K111380 | 000 |
| 00814548012254 | K111380 | 000 |
| 00814548012247 | K111380 | 000 |
| 00815948022355 | K111380 | 000 |