510(k) K140442
K140442 is an FDA 510(k) premarket notification submitted by Medsource International, LLC for the device "MEDSOURCE SELECTABLE IV SET". The FDA issued a decision of Substantially Equivalent on April 22, 2014. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Medsource International, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2014
- Date Received
- February 21, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type