Submission Details
| 510(k) Number | K123734 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 05, 2012 |
| Decision Date | January 17, 2013 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
K123734 is an FDA 510(k) clearance for the BD NEXIVA DIFFUSICS 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 January 17, 2013, 43 days after receiving the submission on December 5, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K123734 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 05, 2012 |
| Decision Date | January 17, 2013 |
| Days to Decision | 43 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 |