The following data is part of a premarket notification filed by Vitaphore Corp. with the FDA for Vitapatch Cath. Securement Device W/chlorhexidine.
| Device ID | K896046 |
| 510k Number | K896046 |
| Device Name: | VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | VITAPHORE CORP. 1505 O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Sophia Pesotchinsky |
| Correspondent | Sophia Pesotchinsky VITAPHORE CORP. 1505 O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-17 |
| Decision Date | 1990-01-11 |