Identity
- Trade Name
- SoundBite® Active Wire 14P FDA UDI
- Generic Name
- Peripheral vascular guidewire, manual FDA UDI
- Device Name
- The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System - Peripheral (14P) is supplied sterile, has a maximum outer diameter of 0.014” in its usable length (145 cm) and is 300 cm long. Only the distal 145 cm of the SoundBite® Active Wire 14P is ever in contact with patient vasculature. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console. FDA UDI
- Model / Reference
- 900-0001885 FDA UDI
- Description
- The SoundBite® Active Wire 14P which is part of the SoundBite® Crossing System - Peripheral (14P) is supplied sterile, has a maximum outer diameter of 0.014” in its usable length (145 cm) and is 300 cm long. Only the distal 145 cm of the SoundBite® Active Wire 14P is ever in contact with patient vasculature. At the proximal end of the SoundBite® Active Wire 14P, a section reducer allows the wire to be connected to the SoundBite® Console. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17540265101024 FDA UDI
- 510(k) Number
- K210839 FDA UDI
- FDA Product Code
- PDU FDA UDI
- GMDN Term
- Peripheral vascular guidewire, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Guidewire Length — 300 Centimeter FDA UDIGuidewire Diameter — 0.014 Inch FDA UDI
Category: Peripheral vascular guidewire, manual
SoundBite® Active Wire 14P by Soundbite Medical Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Soundbite Medical Solutions, Inc.
Sources (1)
- FDA UDI 7a1f5ce5-f7a7-4a1e-8e2f-46d6b675a19e 36 fields · synced May 30, 2026