The following data is part of a premarket notification filed by Schiff & Co. with the FDA for Vygon Double Lumen Umbilical Catheter.
| Device ID | K981630 |
| 510k Number | K981630 |
| Device Name: | VYGON DOUBLE LUMEN UMBILICAL CATHETER |
| Classification | Catheter, Umbilical Artery |
| Applicant | SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Anne M Cesario |
| Correspondent | Anne M Cesario SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-07 |
| Decision Date | 1998-10-01 |