The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Epicutaneo-cava Catheter Code 2184.
| Device ID | K897168 |
| 510k Number | K897168 |
| Device Name: | EPICUTANEO-CAVA CATHETER CODE 2184 |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | VYGON CORP. 227 BROADWAY SUITE 100 New York, NY 10007 |
| Contact | Harry A Schlakman |
| Correspondent | Harry A Schlakman VYGON CORP. 227 BROADWAY SUITE 100 New York, NY 10007 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-27 |
| Decision Date | 1990-04-23 |