Identity
- Trade Name
- SOUNDSTAR FDA UDI
- Generic Name
- Intracardiac ultrasound imaging catheter, steerable, single-use FDA UDI
- Device Name
- SoundStar eco 8F G Catheter FDA UDI
- Model / Reference
- 10439236 FDA UDI
- Description
- SoundStar eco 8F G Catheter FDA UDI
Identifiers
- Catalog Number
- 10439236 FDA UDI
- Primary DI / UDI-DI
- 10846835008869 FDA UDI
- 510(k) Number
- K140318 FDA UDI
- FDA Product Code
- OBJ FDA UDI
- GMDN Term
- Intracardiac ultrasound imaging catheter, steerable, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intracardiac ultrasound imaging catheter, steerable, single-use
Soundstar by Biosense Webster Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracardiac ultrasound imaging catheter, steerable, single-use.
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- ViewFlex™ — IRVINE BIOMEDICAL, INC. · Class II
- AcuNav V 10F Ultrasound Catheter — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- AcuNav Crystal Ultrasound Catheter — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Foresight ICE™ Catheter — Conavi Medical Inc · Class II
Cleared under the same submission
K140318 also covers:
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
- Biosense Webster Inc
Sources (1)
- FDA UDI abbdb777-abf3-4c88-a464-85818817c5ea 37 fields · synced May 30, 2026