510(k) K180275
K180275 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "VAMP Optima closed blood sampling system". The FDA issued a decision of Substantially Equivalent on Oct 24, 2018. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Edwards Lifesciences, LLC has 157 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 24, 2018
- Date Received
- Jan 31, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type
- 510(k)