The EndoWave Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Device Story
EndoWave Infusion System; disposable infusion catheter with removable ultrasound core; control instrument generates/delivers energy. Catheter features multiple side holes in treatment zone; ultrasound core contains up to 30 elements; thermal sensors monitor temperature. Used in clinical setting by physicians for peripheral vasculature infusion. Device delivers fluids while ultrasound energy potentially enhances thrombolytic effect. Modification involves revised acoustic protocol; system maintains original technological characteristics.
Clinical Evidence
Bench testing only. Testing confirmed revised acoustic protocol remains safe and ultrasound core operates as required.
Technological Characteristics
Disposable infusion catheter with removable ultrasound core; instrument for energy delivery. Up to 30 ultrasound elements; thermal sensors for temperature monitoring. Modification: revised acoustic protocol.
Indications for Use
Indicated for patients requiring controlled, selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Regulatory Classification
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
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SPECIAL 510(k) Notification EndoWave™ Infusion System
#### 510(k) Summary Section 4.
General Provisions
Submitter's Name and Address:
EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011
Catheter, Continuous Flush (KRA)
Contact Person:
Jocelyn Kersten 425-415-3132 425-415-3102 (fax) jkersten@EKOSCORP.com
Classification Name:
Regulation Number:
21 CFR §870.1210
Continuous Flush Catheter
Proprietary Name:
Name of Predicate Device:
Common or Usual Name:
EndoWave Infusion System
EndoWave Infusion System
K072507, K062508 510(k) Reference No .:
### Device Description
The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature.
### Intended Use
The EndoWave Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
## Summary of Technological Characteristics
The device modification described in this notification does not affect the technological characteristics for the EndoWave Infusion System.
### Test Summary
Testing confirmed the revised acoustic protocol remains safe and the ultrasound core will operate as required with the new protocol.
# APR 3 0 2008
