510(k) K861586
K861586 is an FDA 510(k) premarket notification submitted by Icu Medical, Inc. for the device "LOPEZ VALVE". The FDA issued a decision of Substantially Equivalent on August 18, 1986. The device falls under product code MJF (Check Valve, Retrograde Flow (In-Line)), a Class II device regulated under 21 CFR 880.5440. Icu Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1986
- Date Received
- April 29, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Check Valve, Retrograde Flow (In-Line)
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type