The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Duoflo 6f.
| Device ID | K833303 |
| 510k Number | K833303 |
| Device Name: | DUOFLO 6F |
| Classification | Catheter, Percutaneous |
| Applicant | ARGON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-23 |
| Decision Date | 1983-12-27 |