510(k) K133073
K133073 is an FDA 510(k) premarket notification submitted by Cair Lgl for the device "CAIR DRIVE, NEUTRACLEAR". The FDA issued a decision of Substantially Equivalent on March 20, 2014. 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
- March 20, 2014
- Date Received
- September 30, 2013
- 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