510(k) K220288
K220288 is an FDA 510(k) premarket notification submitted by Np Medical, Inc. for the device "NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector". The FDA issued a decision of Substantially Equivalent on April 19, 2023. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Np Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 2023
- Date Received
- February 1, 2022
- 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