The following data is part of a premarket notification filed by Catheter Technology Corp. with the FDA for Umbilical Vessel Catheter.
| Device ID | K840339 |
| 510k Number | K840339 |
| Device Name: | UMBILICAL VESSEL CATHETER |
| Classification | Catheter, Umbilical Artery |
| Applicant | CATHETER TECHNOLOGY CORP. 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 | 1984-01-25 |
| Decision Date | 1984-07-25 |