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510(k) K051225

EKOS MICRO-INFUSION SYSTEM by Ekos Corp. — Product Code NUI

K051225 is an FDA 510(k) premarket notification submitted by Ekos Corp. for the device "EKOS MICRO-INFUSION SYSTEM". The FDA issued a decision of SESU on June 10, 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
June 10, 2005
Date Received
May 12, 2005
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.

Other clearances by Ekos Corp.

  • K081467 — EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION (June 26, 2008)
  • K080392 — EndoWave Infusion System (April 30, 2008)
  • K073166 — ENDOWAVE INFUSION SYSTEM (April 22, 2008)
  • K072507 — ENDOWAVE INFUSION SYSTEM (October 4, 2007)
  • K071933 — ENDOWAVE INFUSION SYSTEM (August 10, 2007)
  • K063620 — EKOS MICRO-INFUSION SYSTEM (August 6, 2007)
  • K062508 — NEUROWAVE MICRO-INFUSION SYSTEM (December 5, 2006)
  • K062507 — MICRO-INFUSION SYSTEM (November 22, 2006)
  • K060422 — LYSUS INFUSION SYSTEM (March 9, 2006)
  • K060084 — LYSUS INFUSION SYSTEM (February 7, 2006)

Other clearances for product code NUI

  • K062508 — NEUROWAVE MICRO-INFUSION SYSTEM (December 5, 2006)
  • K053437 — EKOS MICRO-INFUSION SYSTEM (January 6, 2006)
  • K041826 — EKOS ULTRASOUND INFUSION SYSTEM (April 27, 2005)

FDA data resources