The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Polyurethane Venous/arterial Xro Umbil. Cath.
| Device ID | K921352 |
| 510k Number | K921352 |
| Device Name: | VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH |
| Classification | Catheter, Umbilical Artery |
| Applicant | VYGON CORP. 304 VERONA AVE. Elizabeth, NJ 07208 |
| Contact | Harry Schlakman |
| Correspondent | Harry Schlakman VYGON CORP. 304 VERONA AVE. Elizabeth, NJ 07208 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-19 |
| Decision Date | 1992-10-26 |