The following data is part of a premarket notification filed by Avant Medical Corporation with the FDA for Avant Guardian 101.
| Device ID | K024018 |
| 510k Number | K024018 |
| Device Name: | AVANT GUARDIAN 101 |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | AVANT MEDICAL CORPORATION 3914 KENDALL ST. San Diego, CA 92109 |
| Contact | John B Slate |
| Correspondent | John B Slate AVANT MEDICAL CORPORATION 3914 KENDALL ST. San Diego, CA 92109 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-04 |
| Decision Date | 2003-01-17 |
| Summary: | summary |