The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Coil System/penumbra Coil 400.
| Device ID | K120330 |
| 510k Number | K120330 |
| Device Name: | PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 |
| Classification | Device, Neurovascular Embolization |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Contact | Emilly T Nurthen |
| Correspondent | Emilly T Nurthen PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-02 |
| Decision Date | 2012-04-02 |
| Summary: | summary |