Submission Details
| 510(k) Number | K183399 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 07, 2018 |
| Decision Date | March 20, 2019 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
K183399 is an FDA 510(k) clearance for the BD Nexiva Closed IV Catheter System, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on March 20, 2019, 103 days after receiving the submission on December 7, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K183399 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 07, 2018 |
| Decision Date | March 20, 2019 |
| Days to Decision | 103 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 |