510(k) K222791
K222791 is an FDA 510(k) premarket notification submitted by Lineus Medical, LLC for the device "SafeBreak Vascular". The FDA issued a decision of Substantially Equivalent on October 16, 2022. The device falls under product code QOI (Intravenous Catheter Force-Activated Separation Device.), a Class II device regulated under 21 CFR 880.5220. Lineus Medical, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2022
- Date Received
- September 15, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intravenous Catheter Force-Activated Separation Device.
- Device Class
- Class II
- Regulation Number
- 880.5220
- Review Panel
- HO
- Submission Type
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.