The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Argon Multi-lumen Central Venous Catheter.
| Device ID | K984189 |
| 510k Number | K984189 |
| Device Name: | ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MAXXIM MEDICAL 1445 FLAT CREEK RD. Athens, TX 75751 |
| Contact | Eddie Monroe |
| Correspondent | Eddie Monroe MAXXIM MEDICAL 1445 FLAT CREEK RD. Athens, TX 75751 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-23 |
| Decision Date | 1999-05-05 |
| Summary: | summary |