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 |