The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Double Lumen Picc-catheters (4fr. And 5fr.).
| Device ID | K983544 |
| 510k Number | K983544 |
| Device Name: | VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.) |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Annemarie Cesario |
| Correspondent | Annemarie Cesario VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-09 |
| Decision Date | 1999-01-13 |