510(k) K231724
K231724 is an FDA 510(k) premarket notification submitted by Spm Medicare Pvt. , Ltd. for the device "Flush Syringe (Prefilled 0.9% normal saline solution)". The FDA issued a decision of Substantially Equivalent on November 9, 2023. The device falls under product code NGT (Saline, Vascular Access Flush), a Class II device regulated under 21 CFR 880.5200. Spm Medicare Pvt. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2023
- Date Received
- June 13, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saline, Vascular Access Flush
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.