Identity
- Trade Name
- EkoSonic® FDA UDI
- Generic Name
- Ultrasound thrombolysis system catheter, pulmonary 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
- 6779-002 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
- 500-55112 FDA UDI
- Primary DI / UDI-DI
- 00858593006134 FDA UDI
- FDA Product Code
- KRA FDA UDI
- GMDN Term
- Ultrasound thrombolysis system catheter, pulmonary 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
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Convenience Kit
Yes
FDA UDI
Combination Product
No
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HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
No
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Serial Number
Yes
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Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 106 Centimeter FDA UDI
Category: Ultrasound thrombolysis system catheter, pulmonaryUltrasound thrombolysis system catheter, peripheral
EkoSonic® by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasound thrombolysis system catheter, pulmonary.
- EkoSonic® — Boston Scientific · Class II
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- EKOS™ + — Boston Scientific · Class II
- EkoSonic® — Boston Scientific · Class II
- EkoSonic® — Boston Scientific · Class II
- EKOS™ + — Boston Scientific · Class II
- EkoSonic® — Boston Scientific · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 414a3352-eea3-41cf-ad93-d8c24a196d44 36 fields · synced May 31, 2026