510(k) K230343
K230343 is an FDA 510(k) premarket notification submitted by Epic Medical Pte. , Ltd. for the device "ProSeal Closed System Administration Set". The FDA issued a decision of Substantially Equivalent on November 3, 2023. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Epic Medical Pte. , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2023
- Date Received
- February 8, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type