K111366 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 (BD) (Sandy, US). The FDA issued a Cleared decision on September 30, 2011, 137 days after receiving the submission on May 16, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K111366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2011 |
| Decision Date | September 30, 2011 |
| Days to Decision | 137 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 |