The following data is part of a premarket notification filed by Blockade Medical with the FDA for Barricade Embolization Coil System.
Device ID | K140104 |
510k Number | K140104 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-15 |
Decision Date | 2014-02-13 |
Summary: | summary |