The following data is part of a premarket notification filed by Elucid Bioimaging, Inc. with the FDA for Vascucap.
Device ID | K163071 |
510k Number | K163071 |
Device Name: | VascuCAP |
Classification | System, Image Processing, Radiological |
Applicant | Elucid Bioimaging, Inc. 225 Main Street Suite 15 Wenham, MA 01984 |
Contact | Andrew J. Buckler |
Correspondent | Andrew J. Buckler Elucid Bioimaging, Inc. 225 Main Street Suite 15 Wenham, MA 01984 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-02 |
Decision Date | 2017-05-24 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VASCUCAP 86490940 4887988 Live/Registered |
Elucid Bioimaging Inc. 2014-12-27 |
VASCUCAP 86182064 4636011 Live/Registered |
Elucid Bioimaging Inc. 2014-02-02 |