510(k) K190918
K190918 is an FDA 510(k) premarket notification submitted by Icu Medical for the device "SwabTip Male Disinfectant Cap". The FDA issued a decision of Substantially Equivalent on March 6, 2020. The device falls under product code QBP (Cap, Device Disinfectant), a Class II device regulated under 21 CFR 880.5440. Icu Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2020
- Date Received
- April 9, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cap, Device Disinfectant
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time