K170283 is an FDA 510(k) clearance for the BD Nexiva Diffusics Closed IV Catheter System. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Becton, Dickinson and Company (Sandy, US). The FDA issued a Cleared decision on February 28, 2017, 29 days after receiving the submission on January 30, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K170283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2017 |
| Decision Date | February 28, 2017 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |