The following data is part of a premarket notification filed by Vitaphore Corp. with the FDA for Vitacuff(r) Percutaneous Infect. Control Kit.
| Device ID | K882100 |
| 510k Number | K882100 |
| Device Name: | VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-19 |
| Decision Date | 1988-07-13 |