K890435 is an FDA 510(k) clearance for the VITAACCESS CATHETER INTRODUCER KIT. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Vitaphore Corp. (San Carlos, US). The FDA issued a Cleared decision on March 29, 1989, 61 days after receiving the submission on January 27, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K890435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | January 27, 1989 |
| Decision Date | March 29, 1989 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |