The following data is part of a premarket notification filed by Vitaphore Corp. with the FDA for Vitaguard Percutaneous Infection Control Kit.
| Device ID | K861563 |
| 510k Number | K861563 |
| Device Name: | VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | VITAPHORE CORP. BURDITT, BOWLES & RADZIUS 333 MARKET STREET, SUITE 2220 San Francisco, CA 94105 |
| Contact | Charles L Morin |
| Correspondent | Charles L Morin VITAPHORE CORP. BURDITT, BOWLES & RADZIUS 333 MARKET STREET, SUITE 2220 San Francisco, CA 94105 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-25 |
| Decision Date | 1986-08-27 |