K861479 is an FDA 510(k) clearance for the CAVAFIX, CENTRAL VENOUS CATHETER 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 Burron Medical Products, Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 1, 1986, 70 days after receiving the submission on April 22, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K861479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | April 22, 1986 |
| Decision Date | July 01, 1986 |
| Days to Decision | 70 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 |