The following data is part of a premarket notification filed by Blockade Medical with the FDA for Barricade Embolization Coil System.
| Device ID | K123338 |
| 510k Number | K123338 |
| Device Name: | BARRICADE EMBOLIZATION COIL SYSTEM |
| Classification | Device, Neurovascular Embolization |
| Applicant | BLOCKADE MEDICAL 18 Technology Dr Ste 169 Irvine, CA 92618 |
| Contact | Rebecca K Pine |
| Correspondent | Rebecca K Pine BLOCKADE MEDICAL 18 Technology Dr Ste 169 Irvine, CA 92618 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2013-03-28 |
| Summary: | summary |