The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Heparin Coated Stainless Steel/teflon.
| Device ID | K832030 |
| 510k Number | K832030 |
| Device Name: | HEPARIN COATED STAINLESS STEEL/TEFLON |
| Classification | Fluorometer, Lead (dedicated Instruments) |
| Applicant | ARGON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DOX |
| CFR Regulation Number | 862.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-23 |
| Decision Date | 1983-09-29 |