EKOS CORPORATION

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Catheter, Continuous Flush (KRA) (2)

Premarket Exempt

Clear

EkoSonic® - 00858593006493 Catalog Number : 600-30000

Device Description : The EkoSonic® Control Unit provides power to the Ultrasonic Core and monitors pa The EkoSonic® Control Unit provides power to the Ultrasonic Core and monitors parameters during operation via the CIC. The Control Unit also provides the user interface for operator control. The EkoSonic® Control Unit is intended exclusively for use with the EkoSonic® Device.

Device Class : 2

Duns Number: 943488429

Premarket Exempt : No

Product Code : KRA

Prescription Use : Yes

Device Count : 1

EkoSonic® - 00858593006509 Catalog Number : 700-10302

Device Description : The Connector Interface Cable (CIC) is the cable assembly that connects the Infu The Connector Interface Cable (CIC) is the cable assembly that connects the Infusion Catheter and Ultrasonic Core to the Control Unit.