# K063620: Ekos Micro-Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Ekos Corp.
- Decided: Aug 6, 2007 after 244 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K904788 (1990). 37 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053437: Ekos Micro-Infusion System, Ekos Corp. (2006) Summary page 5.
- K053432: Ekos Micro-Infusion System, Ekos Corp. (2005) Summary page 5.
- K062507: Micro-Infusion System, Ekos Corp. (2006) Summary page 5.
- K062508: Neurowave Micro-Infusion System, Ekos Corp. (2006) Summary page 5.
- K972110: Cordis Endeavor Infusion Catheter, Cordis Corp. (1997) Summary page 5.
- K000177: Renegade HI-Flo Microcatheter, Boston Scientific Corp (2000) Summary page 6.
- K960806: Turbo Tracker, Target Therapeutics (1996) Summary page 6.
- K926243: Angiographic Catheter, Target Therapeutics (1993) Summary page 6.

## Cited in the summary but kept off the family tree
- K944004: Visions 2.9F Ultrasonic Imaging Catheter (Model 84300), Endosonics Corp. (1995). Our reading of the summary gave K944004, FDA’s number for Visions 2.9F Ultrasonic Imaging Catheter (Model 84300) (Endosonics Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “PV 0.018 F/X”. Kept off the family tree. Summary page 6.

## Most influential descendants
- K073166: Endowave Infusion System (2008), 11 descendants of its own
- K081467: Ekosonic Endovascular System with Rapid Pulse Modulation (2008), 10 descendants of its own
- K111705: Ekosonic Endovascular System (2011), 9 descendants of its own
- K183290: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 (2019), 8 descendants of its own
- K192864: UNI*FUSE Infusion System with Cooper Wire (2020), 2 descendants of its own

## Indications for use
The EKOS Micro-Infision System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels. The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature. WARNING: The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS Micro-Infusion system is intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established.

Source page: https://510kreport.com/device/K063620
Methodology: https://510kreport.com/methodology