K231957 is an FDA 510(k) clearance 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 Lineus Medical (Fayetteville, US). The FDA issued a Cleared decision on September 29, 2023, 88 days after receiving the submission on July 3, 2023.
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 | K231957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2023 |
| Decision Date | September 29, 2023 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |