The following data is part of a premarket notification filed by Vasc-alert L.l.c. with the FDA for Vasc-alert.
| Device ID | K030456 |
| 510k Number | K030456 |
| Device Name: | VASC-ALERT |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | VASC-ALERT L.L.C. 1807 W. SUNNYSIDE AVE. SUITE 301 Chicago, IL 60640 |
| Contact | John Kennedy |
| Correspondent | John Kennedy VASC-ALERT L.L.C. 1807 W. SUNNYSIDE AVE. SUITE 301 Chicago, IL 60640 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-11 |
| Decision Date | 2003-07-11 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VASC-ALERT 85033903 3897036 Live/Registered |
Vasc-Alert LLC 2010-05-10 |