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EkoSonic®

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
EkoSonic® FDA UDI
Generic Name
Ultrasound thrombolysis system catheter, peripheral FDA UDI
Device Name
The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic Core. The device delivers physician-specified fluids and ultrasound to the intravascular treatment site. It comes in different working lengths and treatment zones. FDA UDI
Model / Reference
6779-007 FDA UDI
Description
The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic Core. The device delivers physician-specified fluids and ultrasound to the intravascular treatment site. It comes in different working lengths and treatment zones. FDA UDI

Identifiers

Catalog Number
500-55150 FDA UDI
Primary DI / UDI-DI
00858593006189 FDA UDI
FDA Product Code
KRA FDA UDI
GMDN Term
Ultrasound thrombolysis system catheter, peripheral 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

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Serial Number

Yes

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Expiration Date

Yes

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Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 106 Centimeter FDA UDI

Category: Ultrasound thrombolysis system catheter, pulmonaryUltrasound thrombolysis system catheter, peripheral

The EkoSonic Endovascular Device is a single-use, Infusion Catheter with an Ultrasonic Core that delivers physician-specified fluids and ultrasound to the intravascular treatment site. It comes in different working lengths and treatment zones. This device is designed for use in treating peripheral artery clots, and its primary function is to prepare the clot by unwinding fibrin strands before allowing increased drug permeation through the clot.

Similar devices

Also classified as Ultrasound thrombolysis system catheter, pulmonary.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 1ce4ec83-77c4-4604-9ce0-cf13bdf51074 36 fields · synced Jun 29, 2026