Penumbra Smart Coil
Device, Neurovascular Embolization
PENUMBRA, INC.
The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Smart Coil.
Pre-market Notification Details
| Device ID | K160832 |
| 510k Number | K160832 |
| Device Name: | Penumbra Smart Coil |
| Classification | Device, Neurovascular Embolization |
| Applicant | PENUMBRA, INC. ONE PENUMBRA PLACE Alameda, CA 94502 |
| Contact | Charles Denault |
| Correspondent | Charles Denault PENUMBRA, INC. ONE PENUMBRA PLACE Alameda, CA 94502 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-25 |
| Decision Date | 2016-04-20 |
| Summary: | summary |
Trademark Results [Penumbra Smart Coil]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PENUMBRA SMART COIL 86325514 4847087 Live/Registered |
Penumbra, Inc. 2014-07-01 |
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