The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Xro Umbilical Catheter-code 270.
| Device ID | K851005 |
| 510k Number | K851005 |
| Device Name: | XRO UMBILICAL CATHETER-CODE 270 |
| Classification | Catheter, Umbilical Artery |
| Applicant | VYGON CORP. 1 MADISON ST. East Rutherford, NJ 07073 |
| Contact | Tony J Rivers |
| Correspondent | Tony J Rivers VYGON CORP. 1 MADISON ST. East Rutherford, NJ 07073 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-12 |
| Decision Date | 1985-05-21 |