The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Artemis Neuro Evacuation Device.
| Device ID | K171332 |
| 510k Number | K171332 |
| Device Name: | Artemis Neuro Evacuation Device |
| Classification | Endoscope, Neurological |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Mary Rose |
| Correspondent | Mary Rose Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-08 |
| Decision Date | 2017-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548017877 | K171332 | 000 |
| 00814548017860 | K171332 | 000 |
| 00814548017846 | K171332 | 000 |