510(k) K171117
K171117 is an FDA 510(k) premarket notification submitted by Cair Lgl for the device "Carefusion NeutraClear Needle-free connector (EL-NC1000)". The FDA issued a decision of Substantially Equivalent on September 1, 2017. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Cair Lgl has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2017
- Date Received
- April 14, 2017
- 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