The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Multicath Placement Kit.
| Device ID | K901640 |
| 510k Number | K901640 |
| Device Name: | MULTICATH PLACEMENT KIT |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-09 |
| Decision Date | 1990-08-10 |