510(k) K041826
K041826 is an FDA 510(k) premarket notification submitted by Ekos Corp. for the device "EKOS ULTRASOUND INFUSION SYSTEM". The FDA issued a decision of SESU on April 27, 2005. 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
- April 27, 2005
- Date Received
- July 7, 2004
- Clearance Type
- Traditional
- 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.