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 |