The following data is part of a premarket notification filed by Vitaphore Corp. with the FDA for Vitaaccess Catheter Introducer Kit.
| Device ID | K890435 |
| 510k Number | K890435 |
| Device Name: | VITAACCESS CATHETER INTRODUCER KIT |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VITAPHORE CORP. 887 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Jessica Ayres |
| Correspondent | Jessica Ayres VITAPHORE CORP. 887 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-27 |
| Decision Date | 1989-03-29 |