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Ekos™

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
EKOS™ FDA UDI
Generic Name
Ultrasound thrombolysis system control unit FDA UDI
Device Name
The Connector Interface Cable (CIC) is the cable assembly that connects the Infusion Catheter and Ultrasonic Core to the Control Unit. FDA UDI
Model / Reference
EKOS Connector Interface Cable FDA UDI
Description
The Connector Interface Cable (CIC) is the cable assembly that connects the Infusion Catheter and Ultrasonic Core to the Control Unit. FDA UDI

Identifiers

Catalog Number
700-10410 FDA UDI
Primary DI / UDI-DI
00858593006479 FDA UDI
FDA Product Code
KRA FDA UDI
GMDN Term
Ultrasound thrombolysis system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1210 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasound thrombolysis system control unit

Ekos™ by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound thrombolysis system control unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 2881d580-970b-47b1-872e-4f173d761c99 36 fields · synced May 30, 2026