The following data is part of a premarket notification filed by Blockade Medical with the FDA for Barricade Embolization Coil System.
Device ID | K151760 |
510k Number | K151760 |
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 | 2015-06-29 |
Decision Date | 2015-07-27 |
Summary: | summary |