510(k) K062508
K062508 is an FDA 510(k) premarket notification submitted by Ekos Corp. for the device "NEUROWAVE MICRO-INFUSION SYSTEM". The FDA issued a decision of SESU on December 5, 2006. The device falls under product code NUI (Ultrasound, Infusion, System), a Class II device regulated under 21 CFR 870.1200. Ekos Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- December 5, 2006
- Date Received
- August 28, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasound, Infusion, System
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- NE
- Submission Type
For regional infusion of contrast materials into selected vessels in the neuro-vasculature. The device may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.