The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Axiom Femoral Venus Catheter.
| Device ID | K842084 |
| 510k Number | K842084 |
| Device Name: | AXIOM FEMORAL VENUS CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | AXIOM MEDICAL, INC. 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 | 1984-05-24 |
| Decision Date | 1984-08-01 |