DEN190043 is an FDA 510(k) submission for the SafeBreak Vascular. This device is classified as a Intravenous Catheter Force-activated Separation Device. (Class II - Special Controls, product code QOI).
Submitted by Site Saver, Inc. D/B/A Lineus Medical (Fayetteville, US). The FDA issued a Not Cleared (DENG) decision on May 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5220. An Intravenous (iv) Catheter Force-activated Separation Device. An Intravenous Catheter Force-activated Separation Device Is Placed Inline With An Intravenous Catheter And An Intravascular Administration Set, Including Any Administration Set Accessories. It Separates Into Two Parts When A Specified Force Is Applied. The Device Is Intended To Reduce The Risk Of Iv Catheter Failure(s) Requiring Iv Catheter Replacement..
| 510(k) Number | DEN190043 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 18, 2019 |
| Decision Date | May 27, 2021 |
| Days to Decision | 617 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | QOI - Intravenous Catheter Force-activated Separation Device. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5220 |
| Definition | An Intravenous (iv) Catheter Force-activated Separation Device. An Intravenous Catheter Force-activated Separation Device Is Placed Inline With An Intravenous Catheter And An Intravascular Administration Set, Including Any Administration Set Accessories. It Separates Into Two Parts When A Specified Force Is Applied. The Device Is Intended To Reduce The Risk Of Iv Catheter Failure(s) Requiring Iv Catheter Replacement. |