The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Lifecath-picc (pur) Catheters (single And Double Lumen 3fr, 4fr, 4.5fr, And 5fr).
| Device ID | K993442 |
| 510k Number | K993442 |
| Device Name: | VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR) |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff 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 | 1999-10-12 |
| Decision Date | 2000-08-03 |