The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Argon Dual Lumen Hemodialysis, Catheter.
| Device ID | K842039 |
| 510k Number | K842039 |
| Device Name: | ARGON DUAL LUMEN HEMODIALYSIS, CATHETER |
| Classification | Accessories, A-v Shunt |
| Applicant | ARGON MEDICAL CORP. P.O. BOX 1970 Athens, TX 75751 |
| Contact | Dave Baranski |
| Correspondent | Dave Baranski ARGON MEDICAL CORP. P.O. BOX 1970 Athens, TX 75751 |
| Product Code | KNZ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-21 |
| Decision Date | 1985-01-29 |