The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Catheter, Umbilicar Artery.
| Device ID | K771022 |
| 510k Number | K771022 |
| Device Name: | CATHETER, UMBILICAR ARTERY |
| Classification | Catheter, Umbilical Artery |
| Applicant | AXIOM MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-06-06 |
| Decision Date | 1977-11-29 |