FDA.reportPublic FDA data

SoundBite® Active Wire 14P

Primary DI
17540265101024
Brand
SoundBite® Active Wire 14P
Company
Soundbite Medical Solutions Inc
Model
900-0001885
Device 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.
Published
2021-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PDUCatheter For Crossing Total Occlusions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDUCatheter For Crossing Total OcclusionsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210839000SoundBite Crossing System - Peripheral (14P)Soundbite Medical Solutions, Inc.2021-04-20PDU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540265101024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1754026510102417540265101024

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Guidewire Diameter0.014Inch
Guidewire Length300Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-833-312-9181dominique.abecassis@soundbitemedical.com

Regulatory Flags#

DUNS number
208993667
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10754026501023SoundBite® Active Wire 14P900-00018852021-04-30
17540265103028SoundBite® Console9AB-C0010912021-06-30
17540265105022SoundBite® Curving Tool 14900-00012912021-06-30
10754026503027SoundBite® Console9AB-C0010912021-04-30
10754026505021SoundBite® Curving Tool 14900-00012912021-04-30

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Primary DI, Brand, Company table
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00851354004493TigereyeAVINGER, INC.PDU2023-03-14
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