The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Silcath Central Catheter Tray W/18 Ga.
| Device ID | K831453 |
| 510k Number | K831453 |
| Device Name: | SILCATH CENTRAL CATHETER TRAY W/18 GA |
| Classification | Catheter, Infusion |
| Applicant | ARGON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCY |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-05 |
| Decision Date | 1983-07-28 |