The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Embolization Coil System.
| Device ID | K103305 |
| 510k Number | K103305 |
| Device Name: | PENUMBRA EMBOLIZATION COIL SYSTEM |
| Classification | Device, Neurovascular Embolization |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Contact | Seth A Schulman |
| Correspondent | Seth A Schulman 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 | 2010-11-09 |
| Decision Date | 2011-01-26 |
| Summary: | summary |