FDA.reportPublic FDA data

SoundBite® Console

Primary DI
17540265103028
Brand
SoundBite® Console
Company
Soundbite Medical Solutions Inc
Model
9AB-C001091
Device description
The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.e., shock waves) which are transmitted to a connected SoundBite® Active Wire 14P and cause the distal tip of the active wire to move back and forth (axially), acting like a micro-jackhammer. After the passage of each pulse, the tip goes back to its original position.
Published
2021-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
17540265103028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1754026510302817540265103028

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy system generator, mechanical outputA mains electricity (AC-powered) component of a mechanical atherectomy system designed to generate mechanical energy that is typically transmitted through a separate catheter/handpiece for the fragmentation of a chronic partial occlusion (CPO) or chronic total occlusion (CTO) of both coronary and peripheral arteries during an atherectomy procedure. The device may be operated via a remote control or foot-switch and may include an integrated suction/aspiration system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth22Inch
Height42Inch
Weight80Kilogram
Width13Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17540265101024SoundBite® Active Wire 14P900-00018852021-06-30
10754026501023SoundBite® Active Wire 14P900-00018852021-04-30
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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07540299000235PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000242PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000259PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000266PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000273PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
04260279096456BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
04260279096463BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
04260279096470BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
04260279096487BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
00851354004493TigereyeAVINGER, INC.PDU2023-03-14
07290017837109GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
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07290017837222GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
07290017837239GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
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