The following data is part of a premarket notification filed by Vitaphore Corp. with the FDA for Vitaaccess (tm) Catheter Introducer System.
| Device ID | K872998 |
| 510k Number | K872998 |
| Device Name: | VITAACCESS (TM) CATHETER INTRODUCER SYSTEM |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VITAPHORE CORP. 887 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Sophia Pesotchinsky |
| Correspondent | Sophia Pesotchinsky VITAPHORE CORP. 887 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-03 |
| Decision Date | 1988-03-24 |